Alaris 10014914Recalls & reported problems
BD Switzerland Sàrl · Syringe Administration Set, Microbore Tubing, Pressure Sensing Disc 152 cm (60 in) · Class 2
Quick summary
This BD Alaris syringe administration set is intravenous tubing used with syringe pumps. Its 155 reports mostly describe fluid leaking from the set, including at a connector, and some describe blockages and broken parts. The reports include no deaths and 13 injuries, and 142 are malfunctions. No recalls name this device. Reports dropped from 8 in the year before to 3 in the latest year.
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
- 153
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 10885403233906), received between Jul 12, 2018 and Mar 11, 2026 — classified as 13 injuries, 140 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (73 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 Leak73
- Leak/Splash51
- Complete Blockage10
- Appropriate Device Problem Term/Code Not Available5
- Defective Component5
- Restricted Flow rate5
- Break4
- Crack4
Patient problems
- No Consequences Or Impact To Patient76
- No Clinical Signs, Symptoms or Conditions51
- Inadequate Pain Relief8
- Therapeutic Response, Decreased6
- Insufficient Information5
- No Information5
- No Known Impact Or Consequence To Patient4
- Low Blood Pressure/ Hypotension2
Recent adverse event reports
The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2026Complete Blockage
IT WAS REPORTED BY A CUSTOMER THAT THEY HAVE AN ISSUES WITH BD TUBING PRESSURE LIMITS ON OUR SYRINGE PUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24571360 ↗MalfunctionAug 26, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SYRINGE SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE MICROCLAVE WAS LEAKING FLUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22895670 ↗MalfunctionAug 26, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SYRINGE SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE MICROCLAVE WAS LEAKING FLUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22895530 ↗MalfunctionAug 18, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22835725 ↗MalfunctionAug 18, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22835718 ↗MalfunctionAug 8, 2025Break; Break
IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT PRODUCT IS BROKEN AT THE DISC AND WAS LEAKING FLUIDS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22753868 ↗MalfunctionMay 27, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SYRINGE ADMINISTRATION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT WHEN RUNNING IN THE SYRINGE PUMP, AT APPROPRIATE RATES, THEY ARE BEEPING ¿OCCLUDED¿ AND THEN WHEN INSPECTED AND HAND FLUSHED, THEY BEGIN SPRAYING OUT THE SIDE OF THE CONNECTION TO PATIENT OR SPRAYING OUT OF THE DISC.
Patient problems: Insufficient Information
MAUDE report 22092295 ↗MalfunctionMay 19, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT WHEN RUNNING IN THE SYRINGE PUMP, AT APPROPRIATE RATES, THEY ARE BEEPING ¿OCCLUDED¿ AND THEN WHEN INSPECTED AND HAND FLUSHED THEY BEGIN SPRAYING OUT THE SIDE OF THE CONNECTION TO PATIENT OR SPRAYING OUT OF THE DISC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22049105 ↗MalfunctionApr 22, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE TUBING ON PICC LINE CRACKED AND LEAKING. THE BLOOD BACKED UP AND WAS DRIPPING BLOOD FROM LINE ONTO THE FLOOR. TUBING CHANGED PICC LINE FLUSHED AND LINE MAINTAINED. THE MEDLINE (NEAR THE FILTER) WAS WHAT WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21887193 ↗MalfunctionOct 21, 2024Crack; Crack
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20491933 ↗MalfunctionSep 22, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20276001 ↗MalfunctionSep 17, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE MICROBORE TUBING VISIBLY CRACKED AND LEAKING ON BABY-MORPHINE CONTINUOUS DRIP. THIS HAPPENED AT THE LINE OF THE PLASTIC CONNECTION SITE -DISTAL TO THE CYLINDER-SHAPED CONNECTORS CRACKED AT THE CONNECTION OF "WING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20241881 ↗MalfunctionAug 6, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: MED LINE NAD (UNABLE TO IDENTIFY) WAS CRACKED, MORPHINE WAS INFUSING THROUGH THE LINE. LEAKING IDENTIFIED; MED LINE CHANGED. LEAK OCCURRED AT THE PLASTIC PART THAT ATTACHED TO THE AND OR NAD ITSELF. NO BLOOD LOSS OR BLEED BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917057 ↗MalfunctionJul 22, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19798756 ↗MalfunctionJul 8, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD AS SYR PSD MICROBORE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER THE CUSTOMER, VERSED GTT WAS LEAKING AT NAD SITE. (LINE HAS BEEN FLUSHED W/ NS BEFORE ATTACHING)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19690268 ↗MalfunctionJul 8, 2024Leak/Splash; Leak/Splash
ADDITIONAL INFORMATION RECEIVED - PLEASE SEE H TAB. MATERIAL # 10014914, LOT # 2403623. IT WAS REPORTED BY CUSTOMER THAT VERSED GTT WAS LEAKING AT NAD SITE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COMPLAINT - (B)(4). PURCHASE ORDER - (B)(4). ITEM NUMBER - 10014914. DEFECT/COMPLAINT ISSUE - VERSED GTT WAS LEAKING AT NAD SITE (LINE HAS BEEN FLUSHED W/ NS BEFORE ATTACHING) LOT NUMBER - (10)2403623.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19687181 ↗MalfunctionJun 27, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. LEAKING MEDICATION FROM THE CONNECTION OF TUBING AND MICROCLAVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19630614 ↗MalfunctionMay 23, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: THERE WAS A LEAK IN THE TUBING AT THE SITE OF THE TRANSDUCER. IT WAS LEAKING MEDICATION BELOW THE PUMP. ANCEF WAS INFUSING. DELAY IN INFUSION AND TUBING CHANGE WAS REQUIRED. TREATMENT WAS ABLE TO BE COMPLETED. PATIENT STATUS UNAFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19387230 ↗MalfunctionMar 25, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18969010 ↗MalfunctionFeb 17, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18728347 ↗MalfunctionJan 30, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: A CUSTOMER REPORTED A PRODUCT COMPLAINT ON ITEM AL10014914(10014914). THAT WAS SENT IN ON OUR STOCK (B)(4). THE CUSTOMER STATED THAT LEAKING FLUIDS AT PRESSURE DISC.. THEY HAVE 1 EA WITH THE LOT NUMBER OF N/A. WE HAVE SUBMITTED A CIF ON (B)(4). PLEASE ADVISE ON NEXT STEPS FOR US TO RECEIVE CREDIT AND PROVIDE THE RMA/RGA INFORMATION SO THAT WE CAN PROVIDE YOU WITH THE PRODUCT FOR INVESTIGATION. LEAKING FLUIDS AT PRESSURE DISC
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18610432 ↗MalfunctionJan 28, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18592978 ↗MalfunctionJan 18, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM:DESCRIPTION AS REPORTED : MICROBORE TUBING - UNABLE TO PRIME. THE REPORTED PRODUCT EVENT OCCURRED WHILE IN USE WITH A PATIENT BUT NO HARM WAS CAUSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18536845 ↗MalfunctionDec 10, 2023Defective Component; Defective Component
IT WAS REPORTED THAT BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: PRESSURE SENSING DISC TUBING WAS BEING REMOVED FROM PUMP AND TUBING CAME APART. TUBING CAME APART BENEATH PRESSURE SENSING DISC. TUBING WAS NOT CONNECTED TO PATIENT BUT CONTAINED NMBX. 11/15/23. ITEM: 10014914 QUANTITY AFFECTED: 1 EACH. SERIAL/LOT NUMBER: NA.
Patient problems: Insufficient Information
MAUDE report 18298657 ↗MalfunctionDec 3, 2023Optical Discoloration; Optical Discoloration
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18253649 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.