Design OptionsRecalls & reported problems across all models
B. Braun Medical Inc. · 116 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
14 open recalls name at least one Design Options model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 132
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 14
We found 116 models of Design Options by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 132 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2016 and Sep 18, 2026 — classified as 14 injuries, 118 malfunctions.
The most frequently reported specific device problem is “Break” (77 reports).
14 FDA recall records name at least one of these models by its device identifier, 14 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Design Options recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 6, 2026Open, Classified
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
Z-2278-2026 · Root cause: Under Investigation by firm · names 34 of these models · Recall details · FDA record ↗
- Jan 29, 2026Open, Classified
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2270-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 29, 2026Open, Classified
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2269-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 29, 2026Open, Classified
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2268-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 29, 2026Open, Classified
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2267-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 29, 2026Open, Classified
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2266-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 29, 2026Open, Classified
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2265-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 29, 2026Open, Classified
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2264-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 29, 2026Open, Classified
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Z-2263-2026 · Root cause: Process control · Recall details · FDA record ↗
- Sep 18, 2025Open, Classified
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0126-2026 · Root cause: Process control · names 30 of these models · Recall details · FDA record ↗
- Sep 18, 2025Open, Classified
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0125-2026 · Root cause: Process control · Recall details · FDA record ↗
- Sep 18, 2025Open, Classified
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0124-2026 · Root cause: Process control · names 12 of these models · Recall details · FDA record ↗
- Dec 4, 2024Open, Classified
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.
Z-1021-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Jun 5, 2023Open, Classified
Kits were assembled with the incorrect Filter Straw.
Z-2003-2023 · Root cause: Mixed-up of materials/components · names 4 of these models · Recall details · FDA record ↗
Most reported Design Options problems
Device problems
- Break77
- Detachment of Device or Device Component27
- Difficult To Position9
- Difficult to Remove7
- Contamination /Decontamination Problem4
- Material Puncture/Hole2
- Device Contamination with Chemical or Other Material1
- Device Misassembled During Manufacturing /Shipping1
Patient problems
- Foreign Body In Patient50
- No Known Impact Or Consequence To Patient32
- No Clinical Signs, Symptoms or Conditions23
- Needle Stick/Puncture10
- Cerebrospinal Fluid Leakage9
- Pain5
- Headache2
- No Consequences Or Impact To Patient2
Design Options models
116 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Design Options® 552116Epidural anesthesia kit2 recalls7 reports
- Design Options® 530184Spinal epidural anesthesia kit2 recalls1 report
- Design Options® 552126Epidural anesthesia kit2 recalls0 reports
- Design Options® 552177Epidural anesthesia kit2 recalls0 reports
- Design Options® 552179Epidural anesthesia kit2 recalls0 reports
- Design Options® 530159Spinal epidural anesthesia kit2 recalls0 reports
- Design Options® 552155Epidural anesthesia kit1 recall7 reports
- Design Options® 552147Epidural anesthesia kit1 recall6 reports
- Design Options® 560603Spinal anesthesia kit1 recall5 reports
- Design Options® 552176Epidural anesthesia kit1 recall4 reports
- Design Options® 552006Epidural anesthesia kit1 recall4 reports
- Design Options® 555098Epidural anesthesia kit1 recall4 reports
- Design Options® 552076Epidural anesthesia kit1 recall3 reports
- Design Options® 552123Epidural anesthesia kit1 recall2 reports
- Design Options® 552153Epidural anesthesia kit1 recall2 reports
- Design Options® 555422Epidural anesthesia kit1 recall2 reports
- Design Options® 530185Spinal epidural anesthesia kit1 recall1 report
- Design Options® 530029Spinal epidural anesthesia kit1 recall1 report
- Design Options® 530048Spinal epidural anesthesia kit1 recall1 report
- Design Options® 530155Spinal epidural anesthesia kit1 recall1 report
- Design Options® 551028Epidural anesthesia kit1 recall1 report
- Design Options® 551474Epidural anesthesia kit1 recall1 report
- Design Options® 551630Epidural anesthesia kit1 recall1 report
- Design Options® 551769Epidural anesthesia kit1 recall1 report
- Design Options® 555076Epidural anesthesia kit1 recall1 report
- Design Options® 560074Spinal anesthesia kit1 recall1 report
- Design Options® 560533Spinal anesthesia kit1 recall1 report
- Design Options® 560606Spinal anesthesia kit1 recall1 report
- Design Options® 560646Spinal anesthesia kit1 recall1 report
- Design Options® 552133Epidural anesthesia kit1 recall0 reports
- Design Options® 552135Epidural anesthesia kit1 recall0 reports
- Design Options® 552136Epidural anesthesia kit1 recall0 reports
- Design Options® 530180Spinal epidural anesthesia kit1 recall0 reports
- Design Options® 552152Epidural anesthesia kit1 recall0 reports
- Design Options® 560660Spinal anesthesia kit1 recall0 reports
- Design Options® 530194Spinal epidural anesthesia kit1 recall0 reports
- Design Options® 552174Epidural anesthesia kit1 recall0 reports
- Design Options® 560667Spinal anesthesia kit1 recall0 reports
- Design Options® 560670Spinal anesthesia kit1 recall0 reports
- Design Options® 560672Spinal anesthesia kit1 recall0 reports
- Design Options® 552180Epidural anesthesia kit1 recall0 reports
- Design Options® 530197Spinal epidural anesthesia kit1 recall0 reports
- Design Options® 530199Spinal epidural anesthesia kit1 recall0 reports
- Design Options® 530201Spinal epidural anesthesia kit1 recall0 reports
- Design Options® 552192Epidural anesthesia kit1 recall0 reports
- Design Options® 552197Epidural anesthesia kit1 recall0 reports
- Design Options® 530134Spinal epidural anesthesia kit1 recall0 reports
- Design Options® 551749Epidural anesthesia kit1 recall0 reports
- Design Options® 551998Epidural anesthesia kit1 recall0 reports
- Design Options® 555450Epidural anesthesia kit1 recall0 reports
- Design Options® 555484Epidural anesthesia kit1 recall0 reports
- Design Options® 555498Epidural anesthesia kit1 recall0 reports
- Design Options® 555884Epidural anesthesia kit1 recall0 reports
- Design Options® 560214Spinal anesthesia kit1 recall0 reports
- Design Options® 560272Spinal anesthesia kit1 recall0 reports
- Design Options® 560327Spinal anesthesia kit1 recall0 reports
- Design Options® 560394Spinal anesthesia kit1 recall0 reports
- Design Options® 560428Spinal anesthesia kit1 recall0 reports
- Design Options® 560462Spinal anesthesia kit1 recall0 reports
- Design Options® 560465Spinal anesthesia kit1 recall0 reports
- Design Options® 560476Spinal anesthesia kit1 recall0 reports
- Design Options® 560497Spinal anesthesia kit1 recall0 reports
- Design Options® 560513Spinal anesthesia kit1 recall0 reports
- Design Options® 560521Spinal anesthesia kit1 recall0 reports
- Design Options® 560523Spinal anesthesia kit1 recall0 reports
- Design Options® 560538Spinal anesthesia kit1 recall0 reports
- Design Options® 560572Spinal anesthesia kit1 recall0 reports
- Design Options® 560580Spinal anesthesia kit1 recall0 reports
- Design Options® 560584Spinal anesthesia kit1 recall0 reports
- Design Options® 560587Spinal anesthesia kit1 recall0 reports
- Design Options® 560607Spinal anesthesia kit1 recall0 reports
- Design Options® 560609Spinal anesthesia kit1 recall0 reports
- Design Options® 560613Spinal anesthesia kit1 recall0 reports
- Design Options® 560621Spinal anesthesia kit1 recall0 reports
- Design Options® 570246Anesthesia conduction kit1 recall0 reports
- Design Options® 560628Spinal anesthesia kit1 recall0 reports
- Design Options® 530169Spinal epidural anesthesia kit1 recall0 reports
- Design Options® 560645Spinal anesthesia kit1 recall0 reports
- Design Options® 560647Spinal anesthesia kit1 recall0 reports
- Design Options® 560648Spinal anesthesia kit1 recall0 reports
- Design Options® 530160Spinal epidural anesthesia kit1 recall0 reports
- Design Options® 552113Epidural anesthesia kit1 recall0 reports
- Design Options® 530171Spinal epidural anesthesia kit1 recall0 reports
- Design Options® 552119Epidural anesthesia kit1 recall0 reports
- Design Options® 552122Epidural anesthesia kit9 reports
- Design Options® 552175Epidural anesthesia kit5 reports
- Design Options® 570245Anesthesia conduction kit5 reports
- Design Options® 551731Epidural anesthesia kit4 reports
- Design Options® 551875Epidural anesthesia kit4 reports
- Design Options® 555083Epidural anesthesia kit4 reports
- Design Options® 555579Epidural anesthesia kit4 reports
- Design Options® 530193Spinal epidural anesthesia kit3 reports
- Design Options® 555110Epidural anesthesia kit3 reports
- Design Options® 555296Epidural anesthesia kit3 reports
- Design Options® 552101Epidural anesthesia kit3 reports
- Design Options® 555215Epidural anesthesia kit2 reports
- Design Options® 555779Epidural anesthesia kit2 reports
- Design Options® 552079Epidural anesthesia kit2 reports
- Design Options® 552102Epidural anesthesia kit2 reports
- Design Options® 560657Spinal anesthesia kit1 report
Recent Design Options adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Device Contamination with Chemical or Other Material
When opening an epidural kit, a hair was noticed under the gauze and on the sterile drape. The kit was closed and the patient did not come in contact with it. A new kit was obtained, and the patient was prepped and draped. Epidural was placed without incident. The contaminated kit was saved for reporting.No Pt Harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817653 ↗MalfunctionMay 1, 2026Break
AS REPORTED BY THE USER FACILITY: YELLOW INTRODUCER BROKE IN A PATIENTS BACK.
Patient problems: Foreign Body In Patient
MAUDE report 25056311 ↗MalfunctionApr 10, 2026Labelling, Instructions for Use or Training Problem
AS REPORTED BY THE USER FACILITY: CUSTOMER RECEIVED PRODUCT LABELED WITH REF. 551148 BUT THERE IS ANOTHER LABEL STICKER ON THE SIDE THAT REFERENCES ID (B)(4). NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845263 ↗MalfunctionJul 9, 2025Break; Break
AS REPORTED BY THE USER FACILITY: DESCRIPTION OF EVENT: DURING AN EPIDURAL PLACEMENT FOR A PATIENT IN LABOR, THE EPIDURAL CATHETER WAS FOUND TO HAVE SHEARED. THE CATHETER SEPARATED AT THE 5-CENTIMETER MARK. WE BELIEVE IT IS IMPORTANT TO NOTE THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. THE PRACTITIONER'S TECHNIQUE DURING THE PLACEMENT AND/OR REMOVAL ATTEMPT MAY NOT HAVE FOLLOWED ALL RECOMMENDED SAFETY PRECAUTIONS, WHICH COULD HAVE BEEN A CAUSATIVE FACTOR IN THE CATHETER SHEARING. PATIENT STATUS AND MANAGEMENT: THE PATIENT IS CURRENTLY STILL IN LABOR. THE DECISION REGARDING THE MANAGEMENT OF THE RETAINED CATHETER FRAGMENT (IN-SITU VS. SURGICAL REMOVAL) IS CURRENTLY UNDER CONSIDERATION BY THE CLINICAL TEAM, PENDING FURTHER EVALUATION. AN ULTRASOUND WAS PERFORMED, BUT THE FRAGMENT WAS NOT VISUALIZED. A CT SCAN HAS NOT YET BEEN PERFORMED BUT WILL OCCUR AS PART OF THE DIAGNOSTIC WORKUP AFTER PATIENT DELIVERY.
Patient problems: Foreign Body In Patient
MAUDE report 22457225 ↗MalfunctionJun 30, 2025Break; Break
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: SPINAL NEEDLE BROKE OFF INSIDE PATIENT. DETAILED INQUIRY DESCRIPTION: ONE OF THEIR CRNA'S WAS PLACING A SPINAL IN A PATIENT PREOPERATIVELY AS NORMAL PRIOR TO A TOTAL KNEE REPLACEMENT. THIS CRNA IS EXPERIENCED IN SPINALS AND DIDN'T HAVE TO ROUGHLY MANEUVER THE NEEDLE AT ALL. NOTHING OUT OF THE ORDINARY. THIS CRNA THEN FELT THE SPINAL NEEDLE THAT WAS THROUGH THE INTRODUCER "GIVE WAY" AND SAW THAT THE SPINAL NEEDLE HAD BROKEN OFF AT THE HUB. DESCRIBE TYPE OF INTERVENTION: BOARD RUNNER PHYSICIAN ASSISTED WITH THE FULL REMOVAL (WITH THE OR RN GRABBING SOME NECESSARY SUPPLIES).
Patient problems: Foreign Body In Patient
MAUDE report 22366791 ↗MalfunctionJun 17, 2025Break; Break
AS REPORTED BY THE USER FACILITY: WRITING TO REPORT ANOTHER EVENT OF EPIDURAL CATHETER SHEARING. TODAY ON OB, PLACED A ROUTINE EPIDURAL CATHETER ON 1 ATTEMPT. AFTER THREADING THE CATHETER, SHE ATTEMPTED TO REMOVE THE TUOHY VIA PUSH/PULL AND MET RESISTANCE. SHE THEN REMOVED THE ENTIRE TOUHY FROM THE PATIENT'S BACK TO FIND THE CATHETER SHEARED AS YOU SEE BELOW. LUCKILY, AS SHE CONTINUED TO GENTLY PULL, THE TIP OF THE CATHETER CAME OUT, BUT YOU CAN SEE HOW THIN THE REMNANTS ARE. EASILY COULD HAVE BROKEN OFF AND BEEN LODGED IN THE PATIENT'S BACK AND A MAJOR ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22228900 ↗MalfunctionMay 29, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: VERY LARGE SHARD OF GLASS WITHIN GLASS SYRINGE IN SPINAL TRAY. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22106982 ↗MalfunctionMay 12, 2025Break; Difficult to Advance; Break; Difficult to Advance
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CATHETER SHEARING. DETAILED INQUIRY DESCRIPTION UPON CATHETER REMOVAL THE CATHETER APPEARED SHEARED, AND TIP IS MISSING. NO INJURY REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 22005515 ↗MalfunctionMay 9, 2025Break; Break
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BROKEN/SNAPPED FX CATHETER. DETAILED INQUIRY DESCRIPTION: END USER REPORTING A BROKEN FX CATHETER USED ON ONE OF THEIR OR PATIENTS PLACED FOR POST-OP PAIN MANAGEMENT. PATIENT WAS MOVED TO A LATERAL POSITION AND THAT IS WHEN THE CATHETER SNAPPED WITH THE SPRINGWOUND COIL EXPOSED. PER THE DOCTOR, NOTHING UNUSUAL NOTED ABOUT THE CATHETER AND THERE WAS NO EXCESSIVE FORCE OR PULLING OF CATHETER TO HAVE CAUSED THIS. THEY SUSPECT THERE WAS A MATERIAL DEFECT IN THE CATHETER MATERIAL. THEY WERE ONLY VISUALLY ALERTED BY IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997909 ↗MalfunctionApr 1, 2025Break; Break
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION PART OF THE CATHETER WAS RETAINED UPON REMOVAL (SINCE HAS BEEN REMOVED).
Patient problems: Foreign Body In Patient
MAUDE report 21738256 ↗MalfunctionJan 7, 2025Break; Break
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: "DURING INSERTION OF AN EPIDURAL CATHETER ON A PATIENT, A PORTION OF THE PLASTIC COATING ON THE EPIDURAL CATHETER WIRE REMAINED IN THE PATIENT'S BACK WHILE REMOVING THE CATHETER. THE WIRE CAME OUT OF THE PATIENT'S BACK WITH A SECTION OF APPROXIMATELY 10 CM OF THE COATING MISSING." PULLED OUT CATHETER, NO SURGICAL REMOVAL, DISTAL END OF CATHETER. COULD BE IN THE PATIENT STILL.
Patient problems: Foreign Body In Patient
MAUDE report 21091012 ↗MalfunctionOct 30, 2024Break; Difficult to Remove; Break; Difficult to Remove
AS REPORTED BY USER FACILITY: REGISTERED NURSE (RN) ATTEMPTED TO REMOVE EPIDURAL CATHETER FROM PATIENT'S BACK WHILE PATIENT ON HER SIDE AND MET SIGNIFICANT RESISTANCE. HAD PATIENT CURL AROUND ABDOMEN TO OPEN THE SPINAL SPACE. STILL UNABLE TO REMOVE EPIDURAL CATHETER. RN CALLED ANESTHESIA PROVIDER TO COME EVALUATE. ANESTHESIA PROVIDER'S ATTEMPT TO REMOVE EPIDURAL CATHETER AND ALSO MET SIGNIFICANT RESISTANCE. DUE TO PATIENT NOT HAVING MUCH FEELING IN HER LEGS ANESTHESIA PROVIDER DETERMINED THAT MORE TIME SHOULD BE GIVEN FOR SENSATION TO COME BACK TO PATIENT'S LEGS. 30 MIN LATER ANESTHESIA PROVIDER RETURNED TO PATIENT'S BEDSIDE TO REASSESS PATIENT'S SENSATION IN LEGS. SENSATION HAD IMPROVED AND ANESTHESIA PROVIDER ATTEMPTED TO REMOVE EPIDURAL CATHETER WHILE PATIENT WAS SITTING UP HUNCHED OVER ABDOMEN. ANESTHESIA PROVIDER UNABLE TO REMOVE EPIDURAL CATHETER. HAS PATIENT GET ONTO HANDS AND KNEES AND WAS ABLE TO REMOVE EPIDURAL CATHETER AT THIS POINT, BUT THE TIP OF THE CATHETER DID NOT COME OUT. THE CATHETER APPEARED TO HAVE UNCOILED WHERE IT BROKE OFF AND ANESTHESIA PROVIDER ATTEMPTED TO REMOVE THE REST OF THE CATHETER BUT WAS UNSUCCESSFUL. ANESTHESIA PROVIDER DETERMINED THAT PATIENT WA
Patient problems: Foreign Body In Patient
MAUDE report 20567771 ↗MalfunctionOct 16, 2024Break; Break
AS REPORTED, CATHETER SHEAR OFF OF THE WIRE AND THE WIRE ITSELF BECOME LODGED IN A PATIENT'S BACK. PATIENT IS HAVING A XRAY TO BE SURE THAT EVERYTHING IS OUT OF HER BACK AND RESULTS ARE PENDING AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 20467208 ↗MalfunctionOct 10, 2024Break; Break
AS REPORTED BY USER FACILITY, IDENTICAL ISSUES AT WEXFORD. WE HAVE ALSO HAD MANY ISSUES WITH INJECTING THROUGH THE CATHETER AFTER PLACEMENT. FACILITY CONTACT WHO REPORTED THAT DURING OB CASES THE TEST DOSE CAN NOT BE DELIVERED AND THAT SOME OF THE CATHETERS ARE SHEARING. SHE REPORTED THAT THE SAME OUTCOME WAS REQUIRED AS NO BROKEN PIECES FELL OFF IN THE PATIENT BUT A NEW KIT WAS NEEDED AND A NEW CATHETER NEEDED TO BE PLACED.
Patient problems: Needle Stick/Puncture
MAUDE report 20417803 ↗MalfunctionOct 4, 2024Break; Break
AS REPORTED BY THE USER FACILITY: ISSUE: LOSS OF RESISTANCE OBTAINED AT 9CM VIA 17G TUOHY NEEDLE. 19G SPRINGWOUND CATHETER WOULD NOT ADVANCE PAST 11CM (THEREFORE DID NOT ADVANCE PAST TUOHY TIP) AND THEN WOULD NOT RETRACT. AFTER MULTIPLE ATTEMPTS AT REMOVAL OF THE CATHETER FROM THE TUOHY, IT CAME OUT WITH THE BLUE TIP FRAGMENTED OFF. THE FRAGMENT WAS LATER FOUND ON IMAGING TO BE AT L5-S1 EPIDURAL SPACE.
Patient problems: Foreign Body In Patient
MAUDE report 20370996 ↗
Other B. Braun Medical Inc. products
- Infusomat54 models · 2,783 reports · 30 recalls
- IV Administration Set153 models · 281 reports · 68 recalls
- Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
- Outlook25 models · 195 reports · 24 recalls
- Perifix57 models · 224 reports · 20 recalls
- Extension Set41 models · 101 reports · 16 recalls
- Blood Administration Set24 models · 177 reports · 13 recalls
- Caresite23 models · 420 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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