BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RELION INSULIN SYRINGE 1/2 ML, 31 G X 8 MM

    MDR report key: 7004015 · Received November 6, 2017

    Report

    Report Number
    1920898-2017-00310
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 14, 2017
    Report Date
    December 19, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: DEFECT: FOREIGN MATTER, CAT. #: 328509, BATCH#: 7135590, PRODUCT DESCRIPTION: SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL, DATE(S) OF PACKAGING: 30JUN2017 THRU 11JUL2017, MACHINE(S) PACKAGED ON: (B)(4). DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7135590. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. SYRINGE ASSEMBLY ¿ THERE WAS ONE (1) BATCH OF MATERIAL# 8359162 (SYRINGE 0.5ML ASM 31GA 8MM SM700152 SC) THAT WENT INTO THE FINISHED BATCH# 7135590. BATCH# 7170581. A DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7135590. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. SYRINGE ASSEMBLY ¿ THERE WAS ONE (1) BATCH OF MATERIAL# 8359162 (SYRINGE 0.5ML ASM 31GA 8MM SM700152 SC) THAT WENT INTO THE FINISHED BATCH# 7135590. BATCH# 7170581, DATE(S) OF MANUFACTURE: 30JUN2017 THRU 11JUL2017, MACHINE(S) MANUFACTURED ON: (B)(4). THERE WERE TWELVE (12) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THAT THE CONSUMER NOTICED A BUBBLE INSIDE THE BD RELION INSULIN SYRINGE 1/2 ML, 31 G X 8 MM. WHEN THE CN PUT THE SUBSTANCE ON HER FINGER IT FELT LIKE AN OILY SUBSTANCE AND DISCARDED THE PRODUCT. . THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784652 BD RELION INSULIN SYRINGE 1/2 ML, 31 G X 8 MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 7135590

    Patients

    Seq Age Sex Outcome Treatment
    1 Other