BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM

    MDR report key: 6802630 · Received August 17, 2017

    Report

    Report Number
    1920898-2017-00123
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    July 28, 2017
    Report Date
    November 7, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: INVESTIGATION SUMMARY: CUSTOMER RETURNED (6) 1CC, 8MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 7065640. CUSTOMER STATES THAT THE NEEDLES FALL OUT WHEN REMOVING THE NEEDLE FROM VIAL, THE NEEDLE STAYED IN VIAL, THE NEEDLE ARE MISSING, AND CURVED. ALL RETURNED SYRINGES WERE EXAMINED AND 3 OUT OF 6 SAMPLES EXHIBITED A DETACHED CANNULA. THESE SAMPLES WERE EXAMINED UNDER THE MICROSCOPE AND UNDER UV LIGHT AND EXHIBITED ADHESIVE RUNOFF ONTO THE HUB. LITTLE ADHESIVE WAS OBSERVED INSIDE THE HUB. NO BROKEN OR BENT CANNULA WAS OBSERVED. AS PER MANUFACTURING, THERE WERE ZERO (0) DEFECTS OR NOTIFICATIONS NOTED FOR ANY RELATED DEFECTS DURING THE PRODUCTION OF THESE BATCHES. 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). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN AND BENT CANNULA). 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. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME. DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7065640. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. PILS - THERE WERE THREE (3) BATCHES OF MATERIAL# 8359164 (BARREL 1.0ML SHD 31GA 8MM TW (B)(4) WHICH WAS CONSUMED INTO FINAL PRODUCT BATCH# 7065640. BATCH# 7023647, DATE(S) OF MANUFACTURE: 19MAR2017 TO 24MAR2017, MACHINE(S) MANUFACTURED ON: (B)(4). BATCH# 7044560, DATE(S) OF MANUFACTURE: 24MAR2017, MACHINE(S) MANUFACTURED ON: (B)(4). BATCH# 7065640, DATE(S) OF MANUFACTURE: 18APR2017 TO 21APR2017, MACHINE(S) MANUFACTURED ON: (B)(4). THERE WERE ZERO (0) DEFECTS OR NOTIFICATIONS NOTED FOR ANY RELATED DEFECTS DURING THE PRODUCTION OF THESE BATCHES. 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: THE PROBABLE ROOT CAUSES FOR THIS ISSUE ARE: MISADJUSTMENT OF THE ADHESIVE NOZZLE. FLOW ON ADHESIVE NOZZLE IS SET TOO HIGH. SAMPLES WILL BE FORWARDED TO MANUFACTURING ((B)(6)) ON 29SEP2017 FOR FURTHER INVESTIGATION. UPON COMPLETION OF THE SECONDARY INVESTIGATION, A SECOND SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: HOLDREGE RECEIVED SIX (6) 1ML, 8MM, 31G RELION SYRINGES IN OPEN POLYBAG FROM BATCH# 7065640. ALL SAMPLES WERE DECONTAMINATED PRIOR TO EVALUATION. UPON EVALUATION BY QE AH, IT WAS NOTED THAT THREE (3) SAMPLES EXHIBITED INSUFFICIENT ADHESIVE INSIDE THE BARREL TIP, AS OBSERVED UNDER ULTRAVIOLET LIGHTING. THESE SAMPLES ALL WERE RETURNED MISSING THEIR RESPECTIVE CANNULAS AS WELL. FOR EACH OF THE SAMPLES, RUNOVER OF ADHESIVE WAS OBSERVED ON THE EXTERIOR OF THE BARREL TIP, INDICATIVE OF A MISALIGNMENT OF THE ADHESIVE NOZZLE DURING PRODUCTION OF THIS LOT. THE HOLDREGE PLANT IMPLEMENTED UPGRADES TO THE NEEDLE LINES AS PART OF A CONTINUOUS IMPROVEMENT PROJECT. IMPROVEMENTS FOCUSED ON BETTER LIGHTING FOR THE VISION SYSTEM WHICH EVALUATES 100% OF CANNULA DURING PRODUCTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DRAWING UP MEDICATIONS IN A VIAL, USING BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM, THE NEEDLE ¿FELL OUT¿ AND STAYED IN THE MEDICATION VIAL. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582574 BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7065640

    Patients

    Seq Age Sex Outcome Treatment
    1 Other