BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 11205943 · Received January 20, 2021

    Report

    Report Number
    1920898-2021-00094
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 30, 2020
    Report Date
    March 17, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10/D11: CONCOMITANT MEDICAL PRODUCTS: DEVICE AVAILABLE FOR EVAL YES. D10/D11: CONCOMITANT MEDICAL PRODUCTS: RETURNED TO MANUFACTURER ON: 2021-02-09. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED TWO SYRINGES IN A 0.3ML 31 GAUGE 8MM POUCH FROM LOT # 9231336. FOR BOTH SYRINGES, THE NEEDLE HUB HAS SEPARATED FROM THE BARREL. THE HUB IS LODGED IN THE NEEDLE SHIELD. THERE IS NO DAMAGE TO THE CONNECTOR AT THE DISTAL TIP OF THE BARREL OR THE BASE OF THE NEEDLE HUB ON EITHER SYRINGE. BOTH PLUNGER CAPS HAVE BEEN REMOVED BUT THERE ARE NO SIGNS OF USE. NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9231336 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS NOTED FOR CRACKED HUBS BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE FOR BOTH RETURNED SYRINGE. HE CARRIER THAT ASSEMBLES THE COMPONENTS TOGETHER WAS ADJUSTED TO REDUCE THE PRESSURE CAUSING CRACKED HUBS. TOO MUCH PRESSURE WILL PRESSURE MAY CAUSE CRACKED HUBS AND TOO LITTLE OF PRESSURE MAY CAUSE THE HUB TO NOT BE FULLY SEATED. CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL NEEDLE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328512 BATCH NO: 9231336. IT WAS REPORTED THAT THE PER OWNER EXPERIENCED NEEDLE HUB SEPARATION.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL NEEDLE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328512, BATCH NO: 9231336. IT WAS REPORTED THAT THE PER OWNER EXPERIENCED NEEDLE HUB SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102011 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 9231336 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1