BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ 30 ML BULK PACK LUER LOCK TIP

    MDR report key: 13586829 · Received February 23, 2022

    Report

    Report Number
    1911916-2022-00099
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    December 10, 2021
    Report Date
    February 28, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: IT WAS REPORTED THERE WERE MULTIPLE DEFECTS WITH THE PRODUCTS RECEIVED. TO AID IN THE INVESTIGATION, FOURTEEN SAMPLES AND FIVE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. TWO SAMPLES HAVE THE PLUNGER ROD DAMAGED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE FIVE PHOTOS PROVIDED SHOW SOME OF THE SAMPLES RECEIVED. THE PLUNGER ROD DEFECT COULD OCCUR IF THERE WAS A JAM THAT OCCURRED DURING THE PLUNGER ROD ASSEMBLY PROCESS INDUCING THE SYMPTOM REPORTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301033, LOT NUMBER 1180548. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE ASSEMBLY PROCESS WAS PERFORMED. THE SETTINGS AND ALIGNMENT OF THE RAILS WERE CORRECT AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE LUER-LOK¿ 30 ML BULK PACK LUER LOCK TIP APPROXIMATELY 144 PIECES WERE FOUND TO HAVE PHYSICAL DEFECTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301033 BATCH NO: 1180548 IT WAS REPORTED DAMAGED/BROKEN (THUMB PRESS) BAD IMPRESSION DATE: (B)(6) 2021 DAMAGED/BROKEN: 60 PIECES. BAD IMPRESSION: 84 PIECES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE LUER-LOK¿ 30 ML BULK PACK LUER LOCK TIP APPROXIMATELY 144 PIECES WERE FOUND TO HAVE PHYSICAL DEFECTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301033. BATCH NO: 1180548. IT WAS REPORTED DAMAGED/BROKEN (THUMB PRESS) BAD IMPRESSION. DATE: (B)(6) 2021. DAMAGED/BROKEN: 60 PIECES. BAD IMPRESSION: 84 PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847588 BD SYRINGE LUER-LOK¿ 30 ML BULK PACK LUER LOCK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1180548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown