BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS

    MDR report key: 9527197 · Received December 27, 2019

    Report

    Report Number
    1920898-2019-01478
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    December 9, 2019
    Report Date
    January 10, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) LOOSE 0.5ML BD INSULIN SYRINGE. CONSUMER REPORTED NEEDLE BREAK OFF IN SITE (AB) DURING INJECTION. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE CANNULA WAS BROKEN. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THE SAMPLE. THE HUB-END OF THE CANNULA APPEARED TO HAVE BEEN BENT PRIOR TO BREAKING, SUGGESTING A BENDING AND RE-STRAIGHTENING MODE OF FAILURE. SINCE THE SYRINGE WAS RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BROKEN CANNULA IS USER ERROR WHEN USING THE SYRINGE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8232928. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200772181] NOTED FOR ADHESIVE ON CANNULA. THERE WAS ONE (1) NOTIFICATION [200772622] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS EXPERIENCED THE CANNULA BREAKING OFF OR PULLING OUT DURING USE, AND SERIOUS INJURY IN THE FORM OF MEDICAL INTERVENTION. THE CONSUMER STATED THAT THE CANNULA BROKE OFF BENEATH THE SKIN AND THEY WERE UNABLE TO PULL IT OUT. THE CONSUMER SOUGHT URGENT CARE, BUT THERE IS NO ADDITIONAL INFORMATION REGARDING THE OUTCOME OF THE MEDICAL INTERVENTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328468; BATCH NO: 8232928. VERBATIM: ISSUE(S): NEEDLE BREAK OFF IN SITE (AB) DURING INJECTION. DOES NOT REUSE NEEDLES. UNABLE TO PULL OUT ON HER OWN. CONSUMER STATED GOING TO THE URGENT CARE NOW. CAN SEE THE NEEDLE UNDER HER SKIN. LOT #: 8232928; ITEM #: 328468; DATE OF EVENT: (B)(6) 2019.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS EXPERIENCED THE CANNULA BREAKING OFF OR PULLING OUT DURING USE, AND SERIOUS INJURY IN THE FORM OF MEDICAL INTERVENTION. THE CONSUMER STATED THAT THE CANNULA BROKE OFF BENEATH THE SKIN AND THEY WERE UNABLE TO PULL IT OUT. THE CONSUMER SOUGHT URGENT CARE, BUT THERE IS NO ADDITIONAL INFORMATION REGARDING THE OUTCOME OF THE MEDICAL INTERVENTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328468 ; BATCH NO: 8232928. VERBATIM: ISSUE(S): NEEDLE BREAK OFF IN SITE (AB) DURING INJECTION. DOES NOT REUSE NEEDLES. UNABLE TO PULL OUT ON HER OWN. CONSUMER STATED GOING TO THE URGENT CARE NOW. CAN SEE THE NEEDLE UNDER HER SKIN. LOT #: 8232928. ITEM #: 328468. DATE OF EVENT: (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318019 SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8232928 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Other