BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 11499562 · Received March 16, 2021

    Report

    Report Number
    1920898-2021-00305
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 18, 2021
    Report Date
    April 23, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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: 2021-04-21. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) 1/2CC, 6MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 0062085. CUSTOMER STATES THAT THE SYRINGES DO NOT HAVE THE SPACE AFTER THE CAP. BOTH RETURNED SYRINGES WERE EXAMINED AND BOTH PLUNGER RODS WERE OBSERVED TO BE LOCATED AT THE 0 UNIT MARKING. THE PLUNGER RODS SHOULD BE LOCATED BETWEEN THE 0-5UNIT MARKING DURING MANUFACTURING. NO DEFECTS WERE OBSERVED ON THE RETURNED SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0062085. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED PLUNGERS THAT WERE LOOSE/FELL OUT/SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER MENTIONED THAT THIS IS NOT THE FIRST TIME THIS HAS HAPPENED (SHE SENT AN EMAIL TO REPORT THE OLD COMPLAINT), THE OTHER TIME IT WAS MANY YEARS AGO, WHEN CHECKING THE SYRINGE SHE REALIZED THAT IT DOES NOT COME WITH THE VACUUM THAT SHOULD COME, BETWEEN THE PLUNGER AND THE SYRINGE. WHO USES THE MATERIAL IS HER SON WHO HAS DIABETES SINCE THE AGE OF 6 AND TODAY HE IS 33 BUT HIMSELF DOES THE APPLICATION, SHE ONLY OBSERVED THE DEVIATION OF THE MATERIAL. ACCORDING TO THE CUSTOMER, THE SYRINGES DO NOT HAVE THE SPACE AFTER THE CAP.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLES EXPERIENCED PLUNGERS THAT WERE LOOSE FELL OUT SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER MENTIONED THAT THIS IS NOT THE FIRST TIME THIS HAS HAPPENED SHE SENT AN EMAIL TO REPORT THE OLD COMPLAINT. THE OTHER TIME IT WAS MANY YEARS AGO, WHEN CHECKING THE SYRINGE SHE REALIZED THAT IT DOES NOT COME WITH THE VACUUM THAT SHOULD COME, BETWEEN THE PLUNGER AND THE SYRINGE. WHO USES THE MATERIAL IS HER SON WHO HAS DIABETES SINCE THE AGE OF (B) AND TODAY HE IS (B)(6). BUT HIMSELF DOES THE APPLICATION, SHE ONLY OBSERVED THE DEVIATION OF THE MATERIAL. ACCORDING TO THE CUSTOMER, THE SYRINGES DO NOT HAVE THE SPACE AFTER THE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394967 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 0062085

    Patients

    Seq Age Sex Outcome Treatment
    1