BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ INSULIN SYRINGE

    MDR report key: 7881487 · Received September 17, 2018

    Report

    Report Number
    1920898-2018-00712
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Date of Event
    August 26, 2018
    Report Date
    October 15, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917048130
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) 1CC, 8MM, 31G WALGREENS SYRINGES IN AN OPEN POLY BAG FROM LOT # 7170616. CUSTOMER STATES THAT THE NEEDLE SEPARATED FROM THE HUB AND GOT STUCK INSIDE THE MEDICATION VIAL. ONE SYRINGE WAS RETURNED WITH APPROXIMATELY 36 UNITS OF A CLOUDY LIQUID INSIDE THE BARREL. THIS SYRINGE ALSO EXHIBITED A DETACHED CANNULA. THIS SAMPLE WAS EXAMINED UNDER THE MICROSCOPE AND EXHIBITED ADHESIVE RUNOFF ONTO THE BARREL. BOTH REMAINING SYRINGES WERE ALSO EXAMINED AND BOTH ALSO EXHIBITED ADHESIVE RUNOFF ONTO THE BARREL. SAMPLES WERE FORWARDED TO MANUFACTURING (HOLDREGE) ON 28SEP2018 FOR FURTHER REVIEW. ON 01OCT2018, HOLDREGE RECEIVED THREE (3) 1ML, 8MM, 31G WALGREEN'S PRIVATE LABEL SYRINGES IN AN OPENED POLYBAG FROM BATCH# 7170616. ALL SAMPLES ARE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. ADDITIONALLY, ALL SAMPLES WERE VISUALIZED UNDER ULTRAVIOLET LIGHTING AND NOTED ADHESIVE RUN-OVER ONTO THE BARREL TIP AND WELL. FOR THE TWO (2) RETURNED SAMPLES IN WHICH THE CANNULA REMAINED ASSEMBLED WITHIN THE BARREL, INCOMPLETE DISTRIBUTION OF ADHESIVE WITH THE BARREL TIP WAS NOTED, WHICH COULD HAVE POTENTIALLY LED TO CANNULA SEPARATION FROM THE REMAINDER OF THE SYRINGE. PROBABLE ROOT CAUSE FOR ADHESIVE RUN-OVER IS LIKELY TO BE A MISALIGNMENT OF THE ADHESIVE NOZZLE DURING APPLICATION OF ADHESIVE TO THE BARREL. WHEN THIS TYPE OF EVENT OCCURS, ADHESIVE MAY BE FOUND ALONG ANY PORTION OF THE BARREL TIP OR WELL. GENERALLY, THIS CAN LEAD TO A LESS-PERMANENT OR SECURE CURING OF THE CANNULA WITHIN THE BARREL TIP. PROBABLE ROOT CAUSE FOR THE CANNULA SEPARATING FROM THE REMAINDER OF THE DEVICE IS LIKELY DUE TO INSUFFICIENT ADHESIVE WITHIN THE BARREL TIP, AS NOTED THROUGH VISUALIZATION UNDER ULTRAVIOLET LIGHT. WHEN THIS TYPE OF EVENT OCCURS, THERE IS A GREATER RISK OF THE CANNULA SEPARATING FROM REMAINDER OF THE SYRINGE DURING INITIAL ACTIVATION/USE BY THE END USER. THE RESULTING DEVICE IS GENERALLY RENDERED INOPERABLE BY THE END USER. CAPA (B)(4) WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS 1ML CUSTOMER COMPLAINTS, SPECIFICALLY CANNULA SEPARATES AND BENT CANNULA, AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 7170616 WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF ANY CORRECTIVE/PREVENTIVE ACTIONS ASSOCIATED WITH THIS CAPA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7170616. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200702994, 200703313] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR CANNULA SEPARATED IN VIAL ON LOT # 7170616. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ADHESIVE RUNOFF). 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 THE NEEDLE OF THE BD SAFETYGLIDE¿ INSULIN SYRINGE SEPARATED FROM THE HUB WHILE DRAWING MEDICATION. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. UNABLE TO PERFORM DHR DUE TO UNKNOWN LOT NUMBER. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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 THE NEEDLE OF THE BD SAFETYGLIDE¿ INSULIN SYRINGE SEPARATED FROM THE HUB WHILE DRAWING MEDICATION. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720850 BD SAFETYGLIDE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN 00311917048130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other