BD PerisafeRecalls & reported problems across all models
Becton, Dickinson And Company · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls
- 0
We found 11 models of BD Perisafe by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Dec 27, 2017 and Feb 16, 2026 — classified as 23 injuries, 48 malfunctions.
The most frequently reported specific device problem is “Break” (27 reports).
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
Most reported BD Perisafe problems
Device problems
- Break27
- Leak/Splash19
- Complete Blockage4
- Defective Component3
- Packaging Problem3
- Device Markings/Labelling Problem2
- Incomplete or Inadequate Connection2
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Foreign Body In Patient14
- No Known Impact Or Consequence To Patient7
- No Consequences Or Impact To Patient6
- Device Embedded In Tissue or Plaque5
- Insufficient Information2
- Needle Stick/Puncture1
- No Patient Involvement1
BD Perisafe models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Perisafe 400273Anesthesia conduction kit33 reports
- BD Perisafe™ 405079NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)9 reports
- BD Perisafe™ 405138NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)8 reports
- BD Perisafe™ 405164NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)5 reports
- BD Perisafe™ 405148NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)4 reports
- BD Perisafe™ 405074NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)3 reports
- BD Perisafe™ 409442NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)3 reports
- BD Perisafe™ 409443NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)3 reports
- BD Perisafe™ 405078NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- BD Perisafe™ 405133NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
- BD Perisafe™ 405140NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
Recent BD Perisafe adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2026Incomplete or Inadequate Connection
ADDITIONAL INFORMATION: COULD YOU TELL US HOW MANY UNITS HAVE BEEN AFFECTED? 3 UNITS. COULD YOU CONFIRM THE BATCH NUMBER OF THE SAMPLE? 4323628. COULD YOU TELL US THE DATE OF THE INCIDENT IN DD/MM/YYYY? 10/01/2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24345553 ↗InjuryOct 29, 2025Break; Break
MalfunctionAug 27, 2025Leak/Splash; Leak/Splash
IT IS REPORTED LEAKAGE. EVENT DESCRIPTION: AFTER INSERTING THE CATHETER LEAKAGE FOUND IN THE DRESSING. ADDITIONAL INFORMATION: NO PATIENT WERE INFECTED. LEAKAGE WILL AFFECT THE DOSAGE AND ACTION OF DRUG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903094 ↗MalfunctionJul 7, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT IS REPORTED CONNECTION ISSUE WITH NEEDLE AND SYRINGE. EVENT DETAILS: THE NEEDLE DOES NOT FIT PROPERLY WITH THE DIFFERENT SYRINGES THAT WERE TESTED, RESULTING IN LEAKAGE DURING THE ADMINISTRATION OF THE MEDICATION IN THIS CASE FOR ANESTHESIA. ADDITIONAL INFORMATION COULD YOU PLEASE CONFIRM IF THE DIFFERENT SYRINGES TESTED ARE FROM BD? YES. COULD YOU PLEASE PROVIDE THE SYRINGE CATALOG AND LOT NUMBER? 4134412. COULD YOU PLEASE CLARIFY THIS MATCHING PROBLEM USING THE SAME OR DIFFERENT PRODUCT CATALOGS? NO. IS THERE ANY IMPACT FOR THE PATIENT? YES. PROVIDE DETAILS OF THE IMPACT/HARM TO THE PATIENT? DETECTED PRIOR TO ADMINISTRATION WAS THERE EXPOSURE TO BLOOD OR CHEMOTHERAPY ON MUCOUS MEMBRANES OR SKIN (DETAIL)? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22410750 ↗MalfunctionJun 27, 2025Defective Component; Defective Component
IT SEEMED AS IF THERE WAS ONLY ONE HOLE OPEN IN THE CATHETER, EVENT DETAILS: RECEIVED AN EPIDURAL CATHETER DURING LABOR. IN THE DELIVERY ROOM, THE PUMP INDICATES OCCLUSION PRESSURE AFTER APPROXIMATELY 6 ML HAS BEEN ADMINISTERED. THIS HAPPENS SEVERAL TIMES BEFORE I AM CALLED AS AN APS NURSE. VISUALLY, THERE IS NO KINK IN THE PUMP TUBE OR CATHETER. BECAUSE WE USE 3.00 M LINES, OCCLUSION PRESSURE OCCASIONALLY OCCURS. THEREFORE, A SHORTER PUMP TUBE (2.00 M) WAS CONNECTED, BUT WITHOUT RESULT. THE SYRINGE WAS THEN CHANGED WITHOUT RESULT, THE PUMP WAS CHANGED WITHOUT RESULT, AND THE FILTER WAS REPLACED WITHOUT RESULT. THE CATHETER WAS THEN WITHDRAWN 2 CM, BUT THAT DID NOT HELP EITHER. UNFORTUNATELY, THE EPIDURAL WAS CONSIDERED ¿LOST¿. AFTER REMOVING THE EPIDURAL CATHETER, I RECEIVED THE CATHETER AND EXAMINED IT: THERE WAS NO KINK IN THE CATHETER ANYWHERE. THE CATHETER WAS CONNECTED TO THE PUMP (OUTSIDE THE PATIENT) AND THE PUMP STILL GAVE AN OCCLUSION ALARM. FLUSHING BY HAND WAS ALSO ALMOST IMPOSSIBLE: IT SEEMED AS IF THERE WAS ONLY ONE HOLE OPEN IN THE CATHETER: ON THE CATHETER, A FEW MILLIMETERS FROM THE TIP, ONLY ONE DROP CAME OUT OF THE CATHETER. HAS THERE BEEN ANY PATIENT IMPACT (SER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22347241 ↗MalfunctionJun 19, 2025Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE BROKEN. VERBATIM: THE BROKEN NEEDLE I BROUGHT TO YOU WAS A BD NEEDLE, NOT A XXX NEEDLE. THE DOCTOR GIVE IT TO ME TOGETHER WITH THE XXX TRAY, AND I THOUGHT IT WAS A XXX NEEDLE. ADDITIONAL INFORMATION RECEIVED ON 18JUN2025. 1. CAN YOU PLEASE PROVIDE THE MATERIAL NUMBER/ LOT NUMBER OF THE PRODUCT ASSOCIATED WITH REPORTED ISSUE? DON¿T KNOW THE MATERIAL OR LOT NUMBERS. 2. WHEN WAS THE NEEDLE BROKE? DURING OR BEFORE USE? NEEDLE BROKE DURING USE INSIDE PATIENT. 3. DID THE REPORTED ISSUE HAVE ANY IMPACT ON THE PATIENT OR HCP? PATIENT REQUIRED SURGERY TO REMOVE BROKEN NEEDLE FROM THE SPINE.
Patient problems: Foreign Body In Patient
MAUDE report 22289238 ↗MalfunctionMay 27, 2025Material Separation; Material Separation
MATERIAL # 405138, BATCH # 4304716. IT WAS REPORTED BY CUSTOMER THAT WHEN ADVANCING SPINAL NEEDLE, IT SEPARATED AND WAS LODGED IN THE PTS SPINAL. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. ISSUE: WHEN ADVANCING SPINAL NEEDLE, IT SEPARATED AND WAS LODGED IN THE PTS SPINAL COLOMN. PT DID REQUIRE DIGANOSITCS AND SURGER TO REMOVE THE OTHER END. PT HARM: YES.
Patient problems: Foreign Body In Patient
MAUDE report 22086972 ↗MalfunctionMar 25, 2025Material Integrity Problem; Material Integrity Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21689247 ↗MalfunctionFeb 20, 2025Break; Break
MalfunctionFeb 18, 2025Complete Blockage; Complete Blockage
MATERIAL # 405078 BATCH # 4094878 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. 25 X 2 SPINAL NEEDLE WAS BEING USED FOR A PATIENT'S INJECTION, AND WHEN TRYING TO INJECT MEDICATION THERE WAS RESISTANCE AND IT WAS OCCLUDED. NEEDLE WAS REMOVED AND STYLET WAS PLACED BACK IN TO SEE IF THERE WAS STILL AN OCCLUSION. THE STYLET HELPED WITH THE OCCLUSION AND THEN INJECTION WAS ABLE TO BE FINISHED. THIS IS THE SECOND NEEDLE FROM THIS LOT 4094878 TO HAVE AN OCCLUSION AT THE BEGINNING OF PROCEDURE. DATE OF EVENT: (B)(6)2025 NO HARM TO PATIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21407185 ↗MalfunctionJan 13, 2025Difficult to Insert; Difficult to Insert
NEEDLE STUCK WHEN TRYING TO REMOVE FROM SHEATH (SEE PICTURE). NEEDLE RESISTANCE WHEN TRYING TO INSERT INTO INTRODUCER. SCRATCHING FEELING WHEN REMOVING FROM INTRODUCER WHICH BLUNTS THE NEEDLE. OLD PACKAGING OF 405079 (BATCH: 1120615) DOES NOT HAVE ABOVE PROBLEM, PUT TOGETHER IN BOX FOR REFERENCE AND COMPARISON. 405260 INTRODUCER NEEDLE PUT TOGETHER FOR TESTING SCRATCHING SOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21138370 ↗MalfunctionNov 21, 2024Leak/Splash; Leak/Splash
MATERIAL # 405074 BATCH # 4166281. WE HAVE HAD SEVERAL REPORTED EVENTS OF LEAKING WHEN USING THIS SYRINGE WITH A LUER SPINAL NEEDLE (ITEM 405074 22G X 2.5IN QUINCKE NEEDLE) TO ADMINISTER INTRATHECAL CHEMOTHERAPY. THIS IS CAUSING CONCERN DUE TO HAZARDOUS DRUG EXPOSURE AND THE RISK THAT A PATIENT WON¿T RECEIVE THE FULL AMOUNT OF CHEMOTHERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20747334 ↗MalfunctionNov 21, 2024Leak/Splash; Leak/Splash
MATERIAL #: 405074; BATCH#: 4166281. IT WAS REPORTED BY CUSTOMER THAT THEY HAD SEVERAL REPORTED EVENTS OF LEAKING WHEN USING THIS SYRINGE WITH A LUER SPINAL NEEDLE (ITEM 405074 22G X 2.5IN QUINCKE NEEDLE) TO ADMINISTER INTRATHECAL CHEMOTHERAPY. THIS IS CAUSING CONCERN DUE TO HAZARDOUS DRUG EXPOSURE AND THE RISK THAT A PATIENT WON¿T RECEIVE THE FULL AMOUNT OF CHEMOTHERAPY.
Patient problems: Insufficient Information
MAUDE report 20745011 ↗InjuryAug 13, 2024Break; Break
InjuryAug 6, 2024Break; Break
DEAR SIR, MADAM. IT HAS BEEN THREE WEEKS AGO THAT WE CONTACTED YOU CONCERNING THE MATERIAL USED IN THE BD EPIDURAL CATHETER, 20 GAUGE CLOSED END (FOR USE WITH THE 3.5" BD EPIDURAL NEEDLE) - X12938. ON 9 JULY 2024, I WAS INFORMED TEAM HAS SENT THE REQUEST TO THE PRODUCT STEWARDSHIP TEAM ([email protected]). HOWEVER, WE HAVE NOT YET RECEIVED A RESPONSE: ALSO, NOT AFTER SENDING (REMINDER) E-MAILS ON 16-7-2024 (TO [email protected]). THEREFORE, I AM E-MAILING ONCE AGAIN TO REQUEST TO YOU TO INFORM US ON THE USED MATERIAL OF ABOVE-STATED BD EPIDURAL CATHETER. WE NEED THIS INFORMATION URGENTLY, AS THIS BD CATHETER WAS BROKEN OFF DURING INSERTION AND WE NEED THIS INFORMATION FOR DECIDING ON FURTHER IMAGING/DIAGNOSTICS AND CONSIDERATION OF THE NECESSITY OF A SURGICAL PROCEDURE FOR THE PATIENT. I EXPECT A RESPONSE TO OUR REQUEST AT A VERY SOON NOTICE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19924354 ↗
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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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