BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿ NEEDLE

    MDR report key: 14052624 · Received April 8, 2022

    Report

    Report Number
    1920898-2022-00225
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 17, 2022
    Report Date
    April 19, 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

    INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVALUTION ?: YES D.9. RETURNED TO MANUFACTURER ON: 19-APR-2022. H.6. INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 1200370 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CUSTOMER RETURNED SAMPLES AND IMAGES OF A SINGLE 0.3ML SYRINGE. THE THUMBPRESS OF THE SYRINGE IS MISSING. THE DAMAGE TO THE PLUNGER INDICATES IT MAY HAVE BROKEN OFF. BASED ON THE IMAGES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE THUMBPRESS MISSING. ROOT CAUSE: MAINTENANCE DISPATCH (L2L) WAS REVIEWED, AND 2 DISPATCHES WERE OPENED FOR PLUNGER JAMS / NOT FEEDING DOWN THE RAIL. THE PLUNGERS ARE GUIDED DOWN A RAIL, SINGLE FILE, BY THE PLUNGER HEAD. A PLUNGER JAM CAN OCCUR WHEN PLUNGERS CROSS OVER ANOTHER PLUNGER WHEN LEAVING THE BOWL AND TRANSPORTING INTO THE RAIL. WHEN A JAM OCCURS, THE PLUNGERS ARE MANUALLY REMOVED HOWEVER IF THE JAM IS MINOR IT WILL DISSIPATE ON ITS OWN. A "PLUNGER JAM" MAY HAVE WEAKENED THE PLUNGER HEAD PRIOR TO ASSEMBLING THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿ NEEDLE HAD DAMAGED PRODUCT ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT THE THUMB PRESS WAS MISSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿ NEEDLE HAD DAMAGED PRODUCT ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THAT THE THUMB PRESS WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283619 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1200370

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown