BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 8MM 90 BX 450 MO

    MDR report key: 11052521 · Received December 21, 2020

    Report

    Report Number
    1920898-2020-01732
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    November 23, 2020
    Report Date
    January 22, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282913
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) 3/10CC, 8MM, 31G SYRINGES IN OPEN POLY BAGS FROM LOT # 0090638. CUSTOMER STATES THAT THE SCALE MARKINGS WERE NOT ON THE SYRINGE. THE RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED FADED AND MISSING SCALE MARKINGS. NO DEFECTS OF THE SCALE MARKINGS WERE OBSERVED ON EITHER OF THE REMAINING SAMPLES. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATED WHEN REMOVING THE SHIELD. THE RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. THE HUB ASSEMBLY DID NOT SEPARATE FROM THE BARREL FROM EITHER OF THE REMAINING SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0090638 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED FOR OUT OF SPEC SHIELD PULL. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MISSING SCALE MARKINGS. ROOT CAUSE FOR MISSING SCALE MARKINGS. POWER ¿FLICKERING¿ CAUSING LOW AIR PRESSURE. RESET THE VFD ¿ VARIABLE FREQUENCY DRIVE. ROOT CAUSE COULD NOT BE DETERMINED FOR HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. CAPA1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 8MM 90 BX 450 MO EXPERIENCED 2 CASES OF HUB SEPARATION AND 1 CASE OF SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, NEEDLE HUB SEPARATED WHEN REMOVING SHIELD 2 SYRINGES AFFECTED. STATED, NO SCALE MARKINGS ON SYRINGE 1 SYRINGE AFFECTED. LOT: 0090538. CATALOG: 328291. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 8MM 90 BX 450 MO EXPERIENCED 2 CASES OF HUB SEPARATION AND 1 CASE OF SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, NEEDLE HUB SEPARATED WHEN REMOVING SHIELD 2 SYRINGES AFFECTED STATED, NO SCALE MARKINGS ON SYRINGE 1 SYRINGE AFFECTED. LOT: 0090538. CATALOG: 328291. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512310 SYRINGE 0.3ML 8MM 90 BX 450 MO SYRINGE FMF BD MEDICAL - DIABETES CARE 328291 UNKNOWN 00382903282913

    Patients

    Seq Age Sex Outcome Treatment
    1