Alaris 10010570Recalls & reported problems
BD Switzerland Sàrl · Extension Set, Microbore Tubing, 0.2 Micron Low Protein Binding Filter 152 cm (60 in) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BD Alaris extension set is a low-protein-binding filter tubing set used to administer fluids and drugs intravenously. Reports mostly describe the tubing cracking, splitting or leaking, and filters that would not prime or flush, sometimes blocking flow so medication did not reach the patient. There are 29 reports, with 1 injury and no deaths, and no recalls name this device. Reports rose from 2 in the earlier 12 months to 7 in the most recent.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10885403233500), received between Jul 11, 2018 and Jul 27, 2026 — classified as 1 injury, 25 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak11
- Crack7
- Leak/Splash4
- Complete Blockage3
- Material Separation2
- Air/Gas in Device1
- Insufficient Device Problem Information1
Patient problems
- No Consequences Or Impact To Patient13
- No Clinical Signs, Symptoms or Conditions8
- Chemical Exposure2
- No Information1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50035888 ↗MalfunctionJul 27, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50035887 ↗MalfunctionJul 27, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50035850 ↗MalfunctionJul 27, 2026Complete Blockage; Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50035847 ↗MalfunctionJul 30, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING IS OCCLUDED AND WILL NOT FLUSH, STRAIGHT OUT OF THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22667097 ↗MalfunctionJan 22, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21210024 ↗MalfunctionOct 27, 2024Crack; Crack
IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS CRACKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING . IT WAS REPORTED BY THE CUSTOMER THAT FILTER SET 10010570 CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20540985 ↗MalfunctionApr 24, 2023Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED WHILE USING BD ALARIS MICRO EXTENSION SET AIR ENTERED THE LINE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SO THE NURSES HAVE FOUND A FLAW WITH THE BD EXTENSION TUBING THAT IS CURRENTLY BEING STOCKED IN BIN L#94052 . IT TENDS TO SUCK IN AIR. THE NURSES HAVE FOUND A WORK AROUND BY USING A BLUE CLAVE TO PREVENT THIS. BECAUSE NO MATTER HOW MUCH THEY PINCH THE LINE. AIR GET IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16802317 ↗MalfunctionJan 13, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED WHILE USING BD ALARIS MICRO EXTENSION SET COMPONENTS SEPARATED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE INJECTING RADIOACTIVE TRACER THROUGH THE MICROBORE TUBING, THE TUBING ITSELF SPLIT AND CAUSED A LEAK OF RADIOTRACER CAUSING A RADIOACTIVE SPILL REQUIRING SPECIAL CLEANING , CAUSING A DELAY IN PATIENT CARE. 51 PKGS. TUBING IN THE SAME LOT.
Patient problems: Chemical Exposure
MAUDE report 16160172 ↗MalfunctionJan 13, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED WHILE USING BD ALARIS MICRO EXTENSION SET COMPONENTS SEPARATED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE INJECTING RADIOACTIVE TRACER THROUGH THE MICROBORE TUBING, THE TUBING ITSELF SPLIT AND CAUSED A LEAK OF RADIOTRACER CAUSING A RADIOACTIVE SPILL REQUIRING SPECIAL CLEANING , CAUSING A DELAY IN PATIENT CARE. 51 PKGS. TUBING IN THE SAME LOT.
Patient problems: Chemical Exposure
MAUDE report 16160161 ↗MalfunctionAug 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
PRODUCT WAS RECEIVED AS AN UNEXPECTED RETURN WITH AN UNSPECIFIED FAILURE.
Patient problems: No Information
MAUDE report 10376207 ↗MalfunctionJun 28, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN INFUSION OF PRECEDEX WAS NOTED TO BE LEAKING ON THE COUNTER FROM THE CONNECTION OF THE TUBING AND A CAP CONNECTOR WHILE INFUSING ON A PATIENT IN THE NICU. ALTHOUGH REQUESTED, THERE WERE NO FURTHER DETAILS OR INFORMATION PROVIDED AND NO REPORT OF HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8745535 ↗MalfunctionJan 28, 2019Fluid/Blood Leak; Fluid/Blood Leak
PRODUCT RECEIVED UNEXPECTEDLY, THERE WAS A NOTE ATTACHED WITH THE RETURNED PRODUCT THAT STATED; MEDICATION LINE DIFFICULT TO FLUSH, WHEN ADMINISTRATING IV PUSH ATIVAN THE USER NOTICED THAT THE 1.2 MICRON FILTER LEAKED, WASTING ALL OF THE ATIVAN DOSE . IT WAS REPORTED BY THE RN THAT PRIOR TO ADMINISTRATING THE IV PUSH MEDICATION, THE ROLLER CLAMPS WERE DEACTIVATED. THE NOTE ATTACHED TO THE PATIENT INFORMATION STICKER STATED THAT THE EVENT OCCURRED IN NICU. ALTHOUGH SEVERAL ATTEMPTS MADE FOR EVENT DETAILS FROM PRODUCT RECEIVED THERE WAS NO RESPONSE FROM THE CUSTOMER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8283709 ↗MalfunctionJan 28, 2019Crack; Crack
PRODUCT RECEIVED UNEXPECTEDLY, THERE WAS A NOTE ATTACHED WITH THE RETURNED PRODUCT STATED; "WAS PUSHING A MED WHEN FILTER CRACKED." A PATIENT INFORMATION STICKER ATTACHED TO THE NOTE STATED THAT THE EVENT OCCURRED IN THE NICU. ALTHOUGH REQUESTED THE CUSTOMER DID NOT INDICATE ANY PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8283245 ↗MalfunctionJan 11, 2019Crack; Crack
THE CUSTOMER REPORTED THE USER WAS ADMINISTRATING IVP PHENOBARBITAL WHEN THE FILTER "BUSTED". THE IV LINE WAS ATTACHED TO A BROVIAC (2.7 FR. RIGHT IJ) CATHETER. THE FACILITY WENT LIVE A COUPLE OF MONTHS WITH THE FILTER SET HOWEVER IN THE PAST 2 WEEKS, THE NICU HAS NOTICED SEVERAL FILTER EXTENSION SET COMPLAINTS. ALTHOUGH REQUESTED, THE CUSTOMER DID NOT INDICATE ANY PATIENT HARM. THE EVENT OCCURRED IN THE NICU.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8242704 ↗MalfunctionJan 11, 2019Crack; Crack
THE CUSTOMER REPORTED THAT THE USER WAS GIVING AN IV PUSH MEDICATION WHEN THE FILTER "BUSTED". THE FILTER LINE WAS ATTACHED TO THE PATIENTS RIGHT IJ BROVIAC (2.7 FR.) CATHETER. THE FACILITY WENT LIVE A COUPLE OF MONTHS WITH THE FILTER SET HOWEVER IN THE PAST 2 WEEKS, THE NICU HAS NOTICED SEVERAL FILTER EXTENSION SET COMPLAINTS. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8242703 ↗MalfunctionJan 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHEN ATTACHING THE SYRINGE TO THE "MED TUBING" TO ADMINISTER AN IVP MEDICATION, A LEAK WAS NOTICED AT THE FILTER SITE. THE MEDICATION LINE WAS ATTACHED TO BROVIAC 4.2 FR.CATHETER, PLACED AT THE BABY'S RIGHT CHEST WALL. THE FACILITY WENT LIVE A COUPLE OF MONTHS WITH THE FILTER SET HOWEVER IN THE PAST 2 WEEKS, THE NICU HAS NOTICED SEVERAL FILTER EXTENSION SET COMPLAINTS. ALTHOUGH REQUESTED THERE WAS NO INDICATION FROM THE CUSTOMER OF PATIENT HARM. THE VENT OCCURRED IN THE NICU.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8242702 ↗MalfunctionJan 11, 2019Crack; Crack
THE CUSTOMER REPORTED THAT THE USER WAS ADMINISTRATING AN IV PUSH MEDICATION WHEN THE FILTER CRACKED. THE IV LINE WAS ATTACHED TO A BROVIAC 4.2 FR.CATHETER, PLACEMENT AT THE RIGHT SIDE OF THE BABY'S CHEST. THE FACILITY WENT LIVE A COUPLE OF MONTHS WITH THE FILTER SET HOWEVER IN THE PAST 2 WEEKS THE NICU HAS NOTICED SEVERAL FILTER EXTENSION SET COMPLAINTS. ALTHOUGH REQUESTED THE CUSTOMER DID NOT INDICATE ANY PATIENT HARM. THE EVENT OCCURRED IN THE NICU.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8242701 ↗MalfunctionJan 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE "MEDICATION FILTER TUBING", ATTACHED TO A BROVIAC 4.2 FR. CATHETER AT THE LEFT FEMORAL WAS NOT CLAMPED, A WET SPOT WAS NOTICED IN THE PATIENT BED. UPON CLOSER OBSERVATION A LEAK WAS NOTED AT THE FILTER. THE FACILITY WENT LIVE A COUPLE OF MONTHS WITH THE FILTER SET HOWEVER IN THE PAST 2 WEEKS THE NICU HAS NOTICED SEVERAL FILTER EXTENSION SET COMPLAINTS. ALTHOUGH REQUESTED THE CUSTOMER DID NOT INDICATE ANY PATIENT HARM. THE SET WAS IN USE FOR LESS THAN 24 HRS. WHEN THE EVENT OCCURRED. THE EVENT OCCURRED IN THE NICU.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8242680 ↗MalfunctionJan 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER WAS LEAKING UNSPECIFIED FLUIDS WHEN ATTACHED TO LEFT FEMORAL BROVIAC( 4.2 FRENCH ) CATHETER. IT WAS REPORTED THAT THE LINE WAS LAST USED AT 0400 WHEN THE USER FOUND FILTER LEAKING THE IN THE PATIENTS BED. THE FACILITY WENT LIVE A COUPLE OF MONTHS WITH THE FILTER SET HOWEVER IN THE PAST 2 WEEKS THE NICU HAS NOTICED SEVERAL FILTER EXTENSION SET COMPLAINTS. ALTHOUGH REQUESTED THE CUSTOMER DID NOT INDICATE AN PATIENT HARM. THE EVENT OCCURRED IN THE NICU.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8242513 ↗MalfunctionJan 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE USER FLUSHED THE MEDICATION LINE WHEN A LEAK WAS NOTICED AT THE FILTER. IT WAS REPORTED THAT THE SET WAS ATTACHED TO PATIENT PICC(1.9 FR. ) LINE ON BABY'S LEFT FOOT.THE FACILITY WENT LIVE A COUPLE OF MONTHS WITH THE FILTER SET HOWEVER IN THE PAST 2 WEEKS THE NICU HAS NOTICED SEVERAL FILTER EXTENSION SET COMPLAINTS. THERE WAS NO REPORT OF PATIENT HARM. AN INCOMPLETE EVENT DATE DOCUMENTED AS 12/2018. THE EVENT REPORTED IN THE NICU .
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8242482 ↗MalfunctionJan 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER EXTENSION SET LEAKED DURING AN UNSPECIFIED CONTINUOUS INFUSION. THE FACILITY WENT LIVE A COUPLE OF MONTHS WITH THE FILTER SET HOWEVER IN THE PAST 2 WEEKS THE NICU HAS NOTICED SEVERAL FILTER EXTENSION SET COMPLAINTS. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8242104 ↗MalfunctionJan 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A LEAK ON THE SIDE OF THE FILTER EXTENSION SET OF UNSPECIFIED FLUIDS WHEN ADMINISTRATING AN IV PUSH. THE FACILITY WENT LIVE A COUPLE OF MONTHS WITH THE FILTER SET HOWEVER IN THE PAST 2 WEEKS THE NICU HAS NOTICED SEVERAL FILTER EXTENSION SET COMPLAINTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8242103 ↗InjuryJul 13, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A LEAK AT THE FILTER OF THE TUBING THAT WAS INFUSING AN UNSPECIFIED MEDICATION. IT IS UNKNOWN IF THIS CONTRIBUTED TO THE PATIENT DEVELOPING A CLABSI (CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION) ON (B)(6) 2018. THERE WAS NO INTERVENTION OR LASTING HARM REPORTED.
Patient problems: Unspecified Infection
MAUDE report 7685809 ↗MalfunctionJul 11, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT AN INFUSION OF EPINEPHRINE WHICH WAS INFUSING AT 0.3ML/HR WAS NOTED TO BE LEAKING DURING THE DAY SHIFT AND WAS REPLACED WITH A NEW SET WHICH WAS NOTED TO BE LEAKING LATER IN THE DAY. A NEW SET OF TUBING AND SYRINGE WERE PROVIDED WITH NO FURTHER REPORTS OF LEAKING. THE LINE WAS CONNECTED A PATIENT'S PICC LINE THAT FLUSHED WELL. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7679485 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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