BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE

    MDR report key: 14412854 · Received May 16, 2022

    Report

    Report Number
    1920898-2022-00341
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    April 25, 2022
    Report Date
    June 9, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    D10: DEVICE AVAILABLE FOR EVAL?: YES. RETURNED TO MANUFACTURER ON: 13-MAY-2022. H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED 2 SYRINGES. 1 WAS RETURNED IN A POLYBAG FOR 0.3ML, 29 GAUGE, 12.7MM SYRINGES FROM LOT 1200370. NO DAMAGE TO THE SYRINGES AND THEIR NEEDLES WERE FOUND. THE NEEDLE TIPS DID NOT FEATURE ANY FOREIGN MATERIAL AND NO DAMAGE TO THE INSIDE OF THE NEEDLE SHIELDS WAS FOUND. THE SYRINGES WERE USED TO DRAW WATER. THE SYRINGES RETAINED THE WATER DRAWN INTO THEIR BARRELS. HOWEVER, A BEAD OF WATER WOULD FORM MORE THAN HALFWAY DOWN THE LENGTH OF THE NEEDLE. THIS ACTION WAS REPEATED, AND THE BEAD OF WATER WOULD FORM AT THE SAME LOCATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 1200370 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF A HOLE IN THE NEEDLE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NON-BIOLOGICAL FOREIGN MATTER WAS FOUND IN THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THIS IS A REPORT ABOUT A NON-BIOLOGICAL FM. A LIQUID CAME OUT OF THE NEEDLE TIP UPON PRIMING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NON-BIOLOGICAL FOREIGN MATTER WAS FOUND IN THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT A NON-BIOLOGICAL FM. A LIQUID CAME OUT OF THE NEEDLE TIP UPON PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2578421 BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown