BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 8561154 · Received April 29, 2019

    Report

    Report Number
    1911916-2019-00418
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 8, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE (1) SAMPLE AND THREE (3) PHOTOS WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. THE SAMPLE WAS VISUALLY ANALYZED USING UNAIDED VISION. IT WAS OBSERVED THAT THE SAMPLE HAS A STOPPER THAT HAS ¿ROLLED¿ BACK IN ONE (1) AREA. THE THREE (3) PHOTOS PROVIDED BY THE CUSTOMER SHOW THE SAME SAMPLE SHOWING THE ¿ROLLED¿ STOPPER FROM VARIOUS ANGLES. ROLLED STOPPERS CAN OCCUR INTERMITTENTLY DURING ASSEMBLY OF THE SYRINGE WHEN THE PLUNGER ROD AND STOPPER SUBASSEMBLY ARE PRESSED INTO THE SYRINGE BARREL. A MISALIGNMENT BETWEEN THE BARREL AND SUBASSEMBLY CAN CAUSE THE ROLLED STOPPER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE STOPPER WAS DEFECTIVE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301031. BATCH NO. 6020541. IT WAS REPORTED THAT THE PLUNGER STOPPER WAS DEFECTIVE. THIS EMAIL IS TO INFORM YOU ABOUT AN ISSUE THAT WE RECEIVED FROM ONE OF OUR CUSTOMER OF PART NUMBER 67-1293, LOT NUMBER : 16-259396, THEY ARE REPORTING THE SYRINGE PLUNGER DEFECTIVE, TODAY WE RECEIVED THE SAMPLE PIECE, AND WE CONFIRMED THE DEFECT. IT WAS STATED DURING OUT OF PACKAGE AND PRIOR TO PATIENT USE, THE SYRINGE PLUNGER ON DEVICE WAS DEFECTIVE; EVENT DATE WAS UNKNOWN. THE SYRINGE WAS FOUND TO HAVE AN OUT OF PLACE PLUNGER TIP. THE TIP WAS MISS-ASSEMBLED ONTO THE PLUNGER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE STOPPER WAS DEFECTIVE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301031, BATCH NO. 6020541. IT WAS REPORTED THAT THE PLUNGER STOPPER WAS DEFECTIVE. THIS EMAIL IS TO INFORM YOU ABOUT AN ISSUE THAT WE RECEIVED FROM ONE OF OUR CUSTOMER OF PART NUMBER 67-1293, LOT NUMBER : 16-259396, THEY ARE REPORTING THE SYRINGE PLUNGER DEFECTIVE, TODAY WE RECEIVED THE SAMPLE PIECE, AND WE CONFIRMED THE DEFECT. IT WAS STATED DURING OUT OF PACKAGE AND PRIOR TO PATIENT USE, THE SYRINGE PLUNGER ON DEVICE WAS DEFECTIVE; EVENT DATE WAS UNKNOWN. THE SYRINGE WAS FOUND TO HAVE AN OUT OF PLACE PLUNGER TIP. THE TIP WAS MISS-ASSEMBLED ONTO THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356526 BD LUER-LOK SYRINGE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 6020541

    Patients

    Seq Age Sex Outcome Treatment
    1 Other