BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GENERAL PURPOSE SYRINGE 5 ML BULK PACK LUER SLIP TIP

    MDR report key: 14120858 · Received April 15, 2022

    Report

    Report Number
    1213809-2022-00193
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 22, 2022
    Report Date
    May 13, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVALUTION?: YES D.9. RETURNED TO MANUFACTURER ON: 20-APR-2022 H.6. INVESTIGATION: ELEVEN LOOSE SAMPLES AND ONE PHOTOGRAPH OF 5ML SLIP TIP SYRINGES (P/N 301028) WERE RECEIVED AND EVALUATED. SIX OF THE SYRINGES HAD MAJOR DAMAGE TO THE BARREL AND FOUR INCLUDED DAMAGE TO THE PLUNGER ROD. FIVE OF THE SAMPLES HAD DISTORTED STOPPERS. THE PHOTO HAD FIVE SYRINGES, THREE WITH GROSS INK SMEARS NEAR THE FLANGE AREA, ONE WITH DISTORTED STOPPER AND ONE WITH MAJOR DAMAGE. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATIONS. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL, PLUNGER ROD AND DISTORTED STOPPER DEFECTS IS ASSOCIATED WITH THE ASSEMBLY PROCESS AND INK SMEARS DEFECTS IS ASSOCIATED WITH THE MARKER PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 0364108. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH ONE QUALITY NOTIFICATION FOR THESE REPORTED DEFECTS DURING THE PRODUCTION OF THIS BATCH. A REQUALIFICATION WAS PERFORMED AND THE LINE CLEARED OF DEFECTS. HOWEVER, IT IS POSSIBLE A LIMITED NUMBER OF PIECES WITH THIS CONDITION WERE ABLE TO ESCAPE DETECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD GENERAL PURPOSE SYRINGE 5 ML BULK PACK LUER SLIP TIP FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THIS OCCURRED 3 TIMES. THE FOREIGN MATTER COMPLAINT WAS RECORDED BASED ON IMAGE FILES PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLEASE FIND ATTACHED NONCONFORMANCE FOR PN 301028 LOT# 0364108 PRESENTING A REJECTION CONDITION OF DAMAGES IN THE SYRINGE. THIS CHARACTERISTIC IS CAUSE OF NON-CONFORMANCE AND LOT REJECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD GENERAL PURPOSE SYRINGE 5 ML BULK PACK LUER SLIP TIP FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THIS OCCURRED 3 TIMES. THE FOREIGN MATTER COMPLAINT WAS RECORDED BASED ON IMAGE FILES PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLEASE FIND ATTACHED NONCONFORMANCE FOR PN 301028 LOT# 0364108 PRESENTING A REJECTION CONDITION OF DAMAGES IN THE SYRINGE. THIS CHARACTERISTIC IS CAUSE OF NON-CONFORMANCE AND LOT REJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907719 BD GENERAL PURPOSE SYRINGE 5 ML BULK PACK LUER SLIP TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0364108

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown