BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 0.5ML 8MM (5/16") 31G U-100

    MDR report key: 14322165 · Received May 7, 2022

    Report

    Report Number
    1920898-2022-00320
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 15, 2022
    Report Date
    June 6, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 25-APR-2022. H6: INVESTIGATION SUMMARY. CUSTOMER RETURNED 2 POLYBAGS FOR 0.5ML, 31 GAUGE, AND 8MM SYRINGES FROM LOT 1193020 AS WELL AS 2 SIMILAR SYRINGES. ONE OF THE POLYBAGS WAS OBSERVED TO HAVE THE SEAL ON THE REVERSE SIDE OF THE POLYBAG OPEN. THIS SEAL DOES NOT SEEM TO HAVE BEEN FORMED PROPERLY, LEAVING THE POLYBAG OPEN AND PERMITTING SYRINGES TO FALL OUT. THE SYRINGES HAD THEIR NEEDLE SHIELDS AND HUBS SEPARATE FROM THE ASSOCIATED BARRELS. THE HUBS HAVE BECOME LODGED INSIDE THE SHIELDS. THERE IS NO DAMAGE TO EITHER THE CONNECTOR AT THE DISTAL TIP OF THE BARREL OR ITS RESPECTIVE NEEDLE HUB. NO SIGNS OF USE AND NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1193020. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATIONS. CAPA B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED TWICE THAT WHILE USING A BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 0.5ML 8MM (5/16") 31G U-100 90 COUNT, THE HUB ASSEMBLY SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 SYRINGES WHEN REMOVED NEEDLE SHIELD THE HUB ASSEMBLY STAYED WITHIN THE NEEDLE SHIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED TWICE THAT WHILE USING A BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 0.5ML 8MM (5/16") 31G U-100 90COUNT, THE HUB ASSEMBLY SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 SYRINGES WHEN REMOVED NEEDLE SHIELD THE HUB ASSEMBLY STAYED WITHIN THE NEEDLE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067353 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 0.5ML 8MM (5/16") 31G U-100 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1193020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown