BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2"

    MDR report key: 16580101 · Received March 21, 2023

    Report

    Report Number
    1920898-2023-00149
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    February 27, 2023
    Report Date
    June 29, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903266319
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 17-APR-2023. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE SYRINGE INSIDE A CLEAR ZIPPER BAG. THE CUSTOMER'S VERBATIM REPORT IS THAT THE STOPPER WAS NOT MOVED, AND THE DRUG SOLUTION COULD NOT BE ASPIRATED. THE SYRINGE WAS VISUALLY INSPECTED AND WAS FOUND THAT THE STOPPER IS DISCONNECTED FROM THE PLUNGER ROAD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 2052357 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. THERE WERE NO QUALITY NOTIFICATIONS OR DISPATCHES THAT PERTAINED TO THE COMPLAINT; THEREFORE, NO ROOT CAUSE CAN BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2" THE PLUNGER WAS DIFFICULT TO MOVE AND ASPIRATION COULD NOT OCCUR. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER'S VERBATIM REPORT IS THAT THE STOPPER WAS NOT MOVED AND THE DRUG SOLUTION COULD NOT BE ASPIRATED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2" THE PLUNGER WAS DIFFICULT TO MOVE AND ASPIRATION COULD NOT OCCUR. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER'S VERBATIM REPORT IS THAT THE STOPPER WAS NOT MOVED AND THE DRUG SOLUTION COULD NOT BE ASPIRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366852 BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2" PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2052357 00382903266319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown