BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 28GA 1/2IN BLS

    MDR report key: 11382282 · Received February 25, 2021

    Report

    Report Number
    1920898-2021-00226
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 2, 2021
    Report Date
    April 9, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-03-15. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) 1/2CC, 12.7MM, 28G SYRINGES IN SEALED BLISTER PACKS FROM LOT # 0132264. CUSTOMER STATES THAT A DROP OF LIQUID COMES OUT OF THE SYRINGE WHEN PLUNGER IS DEPRESSED. ALL RETURNED SYRINGES WERE TESTED AND 2 OUT OF 10 RETURNED SYRINGES EXHIBITED A CLEAR DROPLET OF MATERIAL COMING OUT THE BARREL WHEN THE PLUNGER ROD WAS FULLY DEPRESSED. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0132264. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION NOTED FOR EXCESSIVE SILICONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 0.5ML 28GA 1/2IN BLS EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULA/IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 329461; BATCH NO. 0132264. BD CANADA RECEIVED A PHONE CALL FROM AN ANIMAL HOSPITAL. A CLIENT HAS BEEN USING ITEM 329461 LOT 0132264. SAYS WHEN THE CLIENT PUSHES FORWARD ON THE SYRINGE PRIOR TO USE, A DROP OF LIQUID COMES OUT OF IT. THIS IS HAPPENING EVERY 4TH OR 6TH SYRINGE, AND CUSTOMER IS WONDERING IF THIS IS NORMAL OR WHAT MAY BE CAUSING THIS TO HAPPEN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 0.5ML 28GA 1/2IN BLS EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULA/IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 329461. BATCH NO. 0132264. BD CANADA RECEIVED A PHONE CALL FROM AN ANIMAL HOSPITAL. A CLIENT HAS BEEN USING ITEM 329461. LOT 0132264. SAYS WHEN THE CLIENT PUSHES FORWARD ON THE SYRINGE PRIOR TO USE, A DROP OF LIQUID COMES OUT OF IT. THIS IS HAPPENING EVERY 4TH OR 6TH SYRINGE, AND CUSTOMER IS WONDERING IF THIS IS NORMAL OR WHAT MAY BE CAUSING THIS TO HAPPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277848 SYRINGE 0.5ML 28GA 1/2IN BLS SYRINGE FMF BD MEDICAL - DIABETES CARE 0132264

    Patients

    Seq Age Sex Outcome Treatment
    1