BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LL BNS

    MDR report key: 19977024 · Received August 13, 2024

    Report

    Report Number
    1213809-2024-00540
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 24, 2024
    Report Date
    September 23, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903096485
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. OTHER LOT NUMBERS INCLUDE1259496, 1331232, 1270510, 1127509, AND 2060651. OTHER EXPIRATION DATES INCLUDE 2026-08-31, 2026-10-31 AND 2027-02-28. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATES ARE 2021-09-16, 2021-11-27, 2021-09-27, 2021-05-07 AND 2022-03-01.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION. NINE SYRINGES OF A 1 ML LL BNS LABELED AS ¿LOT UNKNOWN¿, FIVE SYRINGES OF A 1 ML LL BNS LABELED AS ¿LOT 2133917" AND FOUR PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT ALL SYRINGES PRESENTED EXCESSIVE SILICONE PAST THE STOPPER. POTENTIAL ROOT CAUSE FOR THE EXCESSIVE SILICONE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLES AND PHOTOS ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML LL BNS HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE UNFORTUNATELY RECEIVED A COMPLAINT FROM OUR CUSTOMER DUE TO AN EXCESS OF SILICONE INSIDE THE BARREL OF THE SYRINGE. PLEASE FIND ATTACHED PHOTOS. THE LOT NUMBERS OF THE SYRINGES RELATED TO THIS COMPLAINT ARE 1259496, 1331232, 1270510, 1127509 AND 2060651. PRODUCT CODE: BD309648 WE HAVE ALSO OBSERVED THE SAME ISSUE IN 1ML SYRINGES THAT WE PACKED AND REJECTED INTERNALLY. THE BATCH NUMBER OF THESE SYRINGES IS 2133917, AS A RESULT OF THIS ISSUE (B)(4) UNITS HAVE BEEN REJECTED BY OUR PRODUCTION TEAM. THIS INCIDENT DID NOT CAUSE ANY PATIENT OR USER INJURY AND WAS IDENTIFIED PRIOR TO USE OF THE SYRINGES. WE HAVE LOGGED THIS ISSUE WITH OUR REFERENCE (B)(4). WOULD YOU INVESTIGATE TO DETERMINE THE ROOT CAUSE AND IF APPROPRIATE THE ACTIONS REQUIRED TO PREVENT REOCCURRENCE? SAMPLES OF THESE SYRINGES ARE IMMEDIATELY AVAILABLE FOR RETURN FROM THE ADDRESS BELOW: RIVERSIDE MEDICAL PACKAGING CO LTD NEWMARKET DRIVE DERBY DE24 8SW.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094055 BD SYRINGE 1ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2133917 50382903096485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability| H