BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 6MM 10 BAG 500 NLA

    MDR report key: 9890765 · Received March 27, 2020

    Report

    Report Number
    1920898-2020-00312
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    March 4, 2020
    Report Date
    April 9, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) 1/2CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 9042772. CUSTOMER STATES THAT ONE OF THE SYRINGES, THE PART WHERE THE NEEDLE COMES COMPLETELY STUCK IN THE CAP, CANNOT BE REMOVED. THE SYRINGE WAS RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9042772. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200805546] NOTED FOR RAISED NEEDLE ASSEMBLY. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 1/2CC, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. ROOT CAUSE: NOTIFICATION #200805546 WAS CREATED FOR RAISED NEEDLE ASSEMBLY. THE EXTRA GUIDE ON THE DIAL DID NOT GET REMOVED, AFTER RUNNING NON-CAP PRODUCT. CORRECTIVE ACTION: REMOVED THE EXTRA GUIDE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 6MM 10 BAG 500 NLA NEEDLE HUB SEPARATES FROM THE SYRINGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I BOUGHT 6 BOXES OF SYRINGES, AT THE PHARMACY AND ONE OF THE SYRINGES, THE PART WHERE THE NEEDLE COMES COMPLETELY STUCK IN THE CAP, CAN NOT BE REMOVED. APPARENTLY, IT IS NOT WELL APPRECIATED, DOES NOT BRING NEEDLE. INDICATE IF THE PRODUCT WAS USED IN A MEDICAL PROCEDURE OR FOR CLINICAL DIAGNOSIS. I WAS GOING TO INJECT MY MOM WITH INSULIN. WE HAVE BEEN USING THEIR PRODUCTS FOR YEARS. INDICATE IF THE SITUATION WAS IDENTIFIED BEFORE, DURING OR AFTER THE USE OF THE PRODUCT. BEFORE, WE COULDN'T USE IT. INDICATE IF THE PATIENT REQUIRED MEDICAL OR SURGICAL INTERVENTION DUE TO THE SITUATION REPORTED. DO NOT. DESCRIBE THE CURRENT STATE OF THE PATIENT. WE BUY MORE PRODUCT, HOPING NOT TO FIND THIS DEFECT AGAIN.

    Additional Manufacturer Narrative · 1

    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 SYRINGE 0.5ML 31GA 6MM 10 BAG 500 NLA NEEDLE HUB SEPARATES FROM THE SYRINGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I BOUGHT 6 BOXES OF SYRINGES, AT THE PHARMACY AND ONE OF THE SYRINGES, THE PART WHERE THE NEEDLE COMES COMPLETELY STUCK IN THE CAP, CAN NOT BE REMOVED. APPARENTLY, IT IS NOT WELL APPRECIATED, DOES NOT BRING NEEDLE. INDICATE IF THE PRODUCT WAS USED IN A MEDICAL PROCEDURE OR FOR CLINICAL DIAGNOSIS. I WAS GOING TO INJECT MY MOM WITH INSULIN. WE HAVE BEEN USING THEIR PRODUCTS FOR YEARS. INDICATE IF THE SITUATION WAS IDENTIFIED BEFORE, DURING OR AFTER THE USE OF THE PRODUCT. BEFORE, WE COULDN'T USE IT. INDICATE IF THE PATIENT REQUIRED MEDICAL OR SURGICAL INTERVENTION DUE TO THE SITUATION REPORTED. DO NOT. DESCRIBE THE CURRENT STATE OF THE PATIENT. WE BUY MORE PRODUCT, HOPING NOT TO FIND THIS DEFECT AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352881 SYRINGE 0.5ML 31GA 6MM 10 BAG 500 NLA SYRINGE FMF BD MEDICAL - DIABETES CARE 9042772

    Patients

    Seq Age Sex Outcome Treatment
    1 Other