BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX

    MDR report key: 10311605 · Received July 22, 2020

    Report

    Report Number
    1920898-2020-00920
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    July 12, 2020
    Report Date
    July 15, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A 1/2CC SYRINGE. CUSTOMER STATES THAT THERE IS CONTAMINATION IN THE SYRINGE. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED A STRAND OF MATERIAL ON THE BARREL AND PLUNGER ROD. IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THIS MATERIAL SOLELY FROM THE ATTACHED PHOTOS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9252463. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200835583] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR FOREIGN MATTER IN SYRINGE ON LOT # 9140683. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 13 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, FOREIGN MATTER IN SYRINGE) WAS CAPTURED AND ADDRESSED APPROPRIATELY. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THIS MATERIAL SOLELY FROM THE ATTACHED PHOTOS. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "CONTAMINATION IN THE SYRINGE. IT SEEMS TO BE A TEXTILE MATERIAL WHICH THE CUSTOMER FOUND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776023 SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9140683

    Patients

    Seq Age Sex Outcome Treatment
    1 Other