BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.5ML 31GA 8MM

    MDR report key: 12477531 · Received September 15, 2021

    Report

    Report Number
    1920898-2021-00994
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 19, 2021
    Report Date
    September 20, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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: H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (8) LOOSE 0.5ML BD INSULIN SYRINGES. THE CONSUMER REPORTED THE NEEDLE SHIELDS ARE HARD TO REMOVE PRIOR TO INJECTION, AND STATED WHEN HE PULLS HARD ON THE NEEDLE SHIELD THE NEEDLE HUB SEPARATES. ALL 8 RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT 6 WERE RETURNED WITHOUT A NEEDLE HUB/SHIELD ASSEMBLY ATTACHED TO THE BARREL. NO DAMAGE TO THE BARREL TIPS WAS OBSERVED. THE REMAINING 2 SYRINGES WERE TESTED TO DETERMINE THE SHIELD REMOVAL FORCE (SPECS: SHIELD REMOVAL FORCE FOR 0.5 ML SYRINGE AFTER STERILIZATION IS 0.85 TO 5.95LBS) AND THE FOLLOWING WAS OBSERVED: SAMPLE NUMBER SHIELD REMOVAL FORCE (LBS) SAMPLE 1 3.22 SAMPLE 2 3.08 BOTH SYRINGES TESTED WITHIN SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1060385. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE NEEDLE HUB SEPARATES. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SYRINGE 0.5ML 31GA 8MM HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT THE NEEDLE SHIELDS ARE HARD TO REMOVE PRIOR TO INJECTION AND WHEN PULLED HARD ON THE NEEDLE SHIELD THE NEEDLE HUB SEPARATES. DATE OF EVENT : UNKNOWN. SAMPLES : YES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 1 BD SYRINGE 0.5ML 31GA 8MM HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT THE NEEDLE SHIELDS ARE HARD TO REMOVE PRIOR TO INJECTION AND WHEN PULLED HARD ON THE NEEDLE SHIELD THE NEEDLE HUB SEPARATES. DATE OF EVENT : UNKNOWN. SAMPLES : YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373638 BD SYRINGE 0.5ML 31GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1060385

    Patients

    Seq Age Sex Outcome Treatment
    1