BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1 ML LL BNS

    MDR report key: 13624633 · Received February 28, 2022

    Report

    Report Number
    1213809-2022-00104
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    February 15, 2022
    Report Date
    March 23, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT #: ACTUAL LOT NUMBER IS UNKNOWN, HOWEVER THE CUSTOMER SUSPECTS LOTS 0059908 (MFG: 02/29/2020, EXP:02/28/2025), 1083799 (MFG: 03/27/2021, EXP: 02/28/2026), 1127514 (MFG: 05/13/2021, EXP: 04/30/2026), AND 1146636 (MFG: UNKNOWN EXP: UNKNOWN). THE REPORTED LOT # 1146636 WAS NOT FOUND FOR THE REPORTED CATALOG # 309648. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 15-MAR-2022. H.6. INVESTIGATION: TWO PHOTOS AND ONE LOOSE 1ML LUER LOCK SYRINGE (MATERIAL 309648) WERE RECEIVED. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT BARREL HAD A BROWN EMBEDDED FOREIGN MATTER PRESENT ON VARIOUS AREAS. THE OBSERVED CONDITION WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED BD SYRINGE 1 ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED A 1 ML SYRINGE WITH BROWN DISCOLORATION."

    Description of Event or Problem · 0

    IT WAS REPORTED BD SYRINGE 1 ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED A 1 ML SYRINGE WITH BROWN DISCOLORATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862827 BD SYRINGE 1 ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown