BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 11340702 · Received February 17, 2021

    Report

    Report Number
    1920898-2021-00185
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 21, 2021
    Report Date
    March 19, 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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 0160001, D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN , H.4. DEVICE MANUFACTURE DATE: 10/22/2020. D.4. MEDICAL DEVICE LOT #: 0083518, D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, H.4. DEVICE MANUFACTURE DATE: 6/5/2020. D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/16/2021 H.6. INVESTIGATION: CUSTOMER RETURNED TWO SYRINGES IN A SINGLE POUCH IDENTIFYING THEM AS 0.3ML 31 GAUGE 8MM SYRINGES FROM LOT # 0083518. THE FIRST SYRINGE HAD ITS NEEDLE HUB AND SHIELD SEPARATED FROM THE BARREL. THERE WAS NO DAMAGE TO THE CONNECTOR AT THE DISTAL TIP OF THE BARREL OR THE BASE OF THE NEEDLE HUB. NO SIGNS OF USE OR OTHER DAMAGE. THE SECOND SYRINGE WAS RETURNED INTACT. THE NEEDLE SHIELD COULD BE REMOVED FROM THE REST OF THE SYRINGE WITHOUT THE HUB DETACHING FROM THE BARREL. A SHIELD PULL TEST WAS PERFORMED ON THIS SYRINGE, WHICH DETACHED AT 2.39 LBS. THE SPECIFICATION FOR THIS TEST STATES THAT FORCES BETWEEN 0.85 LBS AND 5.95 LBS ARE ACCEPTABLE, MEANING THAT THE NEEDLE SHIELD IS FUNCTIONING AS INTENDED. COULD NOT REPLICATE REPORTED HUB SEPARATION. NO SIGNS OF USE OR OTHER DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0083518. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200886538] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA#1630423 WAS INITIATED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160001. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. FOR THIS LOT# NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER FOUND TWO SYRINGES THAT THE SHIELD WAS DIFFICULT TO REMOVE AND THE HUB STAYED IN THE SHIELD. VERBATIM: CONSUMER REPORTED FOUND 2 SYRINGES HARD TO REMOVE SHIELD THEN HUB STAYED IN SHIELD WHEN ABLE TO REMOVELOT #: 0160001CATALOG#: 328512DATE OF EVENT: UNKNOWN SAMPLES STATUS MAILING KIT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 2 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER FOUND TWO SYRINGES THAT THE SHIELD WAS DIFFICULT TO REMOVE AND THE HUB STAYED IN THE SHIELD. VERBATIM: CONSUMER REPORTED FOUND 2 SYRINGES HARD TO REMOVE SHIELD THEN HUB STAYED IN SHIELD WHEN ABLE TO REMOVE. LOT #: 0160001CATALOG#: 328512DATE OF EVENT: UNKNOWN SAMPLES STATUS MAILING KIT"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236462 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 SEE H.10 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1