BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL DEVICE BRAND NAME

    MDR report key: 7833640 · Received August 30, 2018

    Report

    Report Number
    1920898-2018-00681
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    August 10, 2018
    Report Date
    October 16, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138383
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED (1) LOOSE 3/10CC SYRINGE. CUSTOMER STATES THAT THE NEEDLE WAS STICKING OUT THE SIDE OF THE SHIELD AND STUCK THE CONSUMER WHEN TRYING TO REMOVE THE SHIELD. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED THE CANNULA THROUGH THE SHIELD, EXPOSING THE CANNULA, WHICH COULD LEAD TO A NEEDLE STICK. SAMPLE WAS FORWARDED TO MANUFACTURING (B)(4) ON 28 SEP2018 FOR FURTHER REVIEW. ON 01OCT2018, (B)(4) RECEIVED ONE (1) LOOSE 0.3ML, 8MM SYRINGE FROM REPORTED BATCH# 8071781. ALL SAMPLES ARE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY (B)(4), SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT (B)(4) WERE NOTED. THE RETURNED SAMPLE'S SHIELD WAS DISASSEMBLED FROM THE REMAINDER OF THE DEVICE. A DEEP GOUGE MARK ON THE INTERIOR OF THE SHIELD WALL WHICH ALIGNED WITH THE HOLD CREATED BY THE PIERCING OF THE CANNULA THROUGH THE SHIELD WAS OBSERVED. ADDITIONALLY, THE TIP OF THE CANNULA WAS NOTED TO HAVE A HOOK AT THE MOST DISTAL POINT OF THE PATIENT END OF THE CANNULA. WHEN TAKEN INTO ACCOUNT, ALL OF THE ABOVE FINDINGS MAY BE INDICATIVE OF A SHIELDING-RELATED MISALIGNMENT ON THE NEEDLE LINES, WHICH RESULTED IN NEEDLE THROUGH SHIELD. FURTHER DRILLING TO A PRECISE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME, GIVEN THE INFORMATION AVAILABLE. THERE WERE NO QUALITY NOTIFICATIONS INITIATED DURING PRODUCTION OF THIS BATCH WHICH RELATE TO THIS COMPLAINT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8071781 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE THROUGH SHIELD AND NEEDLE STICK ON LOT # 8071781. BASED ON THE SAMPLES/PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE RELION INSULIN SYRINGE, THE NEEDLE WAS STICKING OUT THE SIDE OF THE SHIELD AND STUCK THE CONSUMER WHEN TRYING TO REMOVE THE SHIELD. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    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 BEFORE USE OF THE RELION® INSULIN SYRINGE, THE NEEDLE WAS STICKING OUT THE SIDE OF THE SHIELD AND STUCK THE CONSUMER WHEN TRYING TO REMOVE THE SHIELD.THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672761 MEDICAL DEVICE BRAND NAME INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 8071781 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1 Other