BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 1.0ML 31G 6MM S/C U-100 RELION

    MDR report key: 10420326 · Received August 18, 2020

    Report

    Report Number
    1920898-2020-01083
    Event Type
    Injury
    Date Received
    August 18, 2020
    Date of Event
    July 14, 2020
    Report Date
    August 13, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138345
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 181241. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. (B)(4). INVESTIGATION SUMMARY: LEVEL B INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_3__; OCCURRENCE: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR NEEDLE BREAKS OFF DURING USE DUE TO UNKNOWN LOT NUMBER. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 13 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, NEEDLE BREAKS OFF DURING USE) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR NEEDLE BREAKS OFF DURING USE DUE TO UNKNOWN LOT NUMBER. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. 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 SYRINGE 1.0ML 31G 6MM S/C U-100 RELION NEEDLE BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328519 BATCH NO. UNKNOWN (PROVIDED: 181241). IT WAS REPORTED THAT DURING INJECTION THE NEEDLE WAS MISSING FROM SYRINGE. X-RAY WAS PERFORMED AND NEEDLE WAS NOT LOCATED IN SITE. VERBATIM: CONSUMER REPORTED WHEN DID THE INJECTION THE NEEDLE WAS MISSING FROM THE SYRINGE. HUSBAND AND WIFE/PATIENT WENT TO THE ER FOR AN X-RAY. THE X-RAY WAS NOT ABLE TO LOCATE THE NEEDLE IN HER SITE. THE HOSPITAL ADVISED TO LOOK IN CLOTHING OR ON FLOOR. THEY NEVER DID FIND THE NEEDLE. THE HOSPITAL ADVISED TO DISCARD THE SYRINGE IN THEIR HAZARD CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884688 SYRINGE 1.0ML 31G 6MM S/C U-100 RELION PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328519 UNKNOWN 00681131138345

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention