BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE 3/10 ML/CC 31 G X 6 MM HALF UNIT

    MDR report key: 6942473 · Received October 11, 2017

    Report

    Report Number
    1920898-2017-00270
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    September 18, 2017
    Report Date
    November 30, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. PRODUCT DESCRIPTION: SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG, DATE(S) PACKAGING: 25APR2017 THRU 27APR2017, MACHINE(S) PACKAGED ON: (B)(4). DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7065710 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. ASSEMBLED SYRINGES ¿ THERE WAS ONE (1) BATCH OF MATERIAL # 700003988 (SYRINGE 0.3ML ASM 31GA 6MM TW (B)(4)) THAT WENT INTO THE PACKAGED BATCH# 7065710. BATCH# 7086920, DATE(S) OF MANUFACTURE: 22APR2017 THRU 26APR2017, MACHINE(S) MANUFACTURED ON: (B)(4). PRINTED BARRELS ¿ THERE WERE TWO (2) BATCH OF MATERIAL# 700003987 (BARREL 0.3ML PRINTED SM700176) THAT WENT INTO PACKAGED BATCH# 7065710. BATCH# 7103598, DATE(S) OF MANUFACTURE: 22APR2017 THRU 29APR2017, MACHINE(S) MANUFACTURED ON: (B)(4). BATCH# 7093853, DATE(S) OF MANUFACTURE: 14APR2017 THRU 18APR2017, MACHINE(S) MANUFACTURED ON: (B)(4). THERE WERE THREE (3) 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.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE 3/10 ML/CC 31 G X 6 MM HALF UNIT CAME WITH THE STOPPER AT AN ANGLE AND CANNOT DRAW THE ACCURATE DOSE, WHILE THE SCALE MARKING PRINT IS OFF. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718981 BD INSULIN SYRINGE 3/10 ML/CC 31 G X 6 MM HALF UNIT PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 7065710

    Patients

    Seq Age Sex Outcome Treatment
    1 Other