BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 14138417 · Received April 18, 2022

    Report

    Report Number
    1920898-2022-00245
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 24, 2022
    Report Date
    June 15, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1242719, MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026, DEVICE MANUFACTURE DATE: 30-AUG-2021. MEDICAL DEVICE LOT #: 9343317, MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2025, DEVICE MANUFACTURE DATE: 19-DEC-2019. 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: D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 25-APR-2022. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED 3 IMAGES, SHOWING 3 SEPARATE SYRINGES. THE 1ST SYRINGE CANNOT BE FULLY IDENTIFIED USING THE LIMITED INFORMATION AVAILABLE. THE GRADUATION MARKS APPEAR TO BE SLIGHTLY BELOW THEIR INTENDED POSITION AND APPEAR CROOKED. HOWEVER, THESE MARKINGS CANNOT BE DIRECTLY MEASURED USING THE DESIGNATED GRADUATION MARKING GAUGES SINCE THE SAMPLE HAS NOT BEEN RETURNED. THE MARKINGS ARE NOT SUFFICIENTLY OUT OF PLACE TO BE ABLE TO CONFIRM THE ISSUE WITHOUT MEASUREMENT IN THE AFOREMENTIONED GAUGES. THE ISSUE OF A DEFECTIVE SCALE CANNOT BE CONFIRMED WITHOUT DIRECTLY MEASURING THE SYRINGE. THE 2ND IMAGE STATES THAT THE RELATED SYRINGE IS A 0.3ML, 31 GAUGE, 6MM SYRINGE FROM LOT 1242719. THE PLUNGER ROD HAS BROKEN OFF ROUGHLY 1-2CM FROM ITS BASE. THE FRACTURE PROFILE IS NOT VISIBLE FROM THE PROVIDED ANGLE TO SHOW THE NATURE OF THE FRACTURE. NO IMMEDIATELY OBSERVABLE ISSUES WITH THE BLACK RUBBER STOPPER WHICH COULD POTENTIALLY SHOW IF THE PLUNGER HAD ANY DIFFICULTY BEING MOVED IN THE SYRINGE BARREL. THE 3RD IMAGE STATES THAT THE RELATED SYRINGE IS A 0.3ML, 31 GAUGE, 6MM SYRINGE FROM LOT 9343317. THE HORIZONTAL BARS MARKING THE SYRINGE¿S GRADUATION MARKINGS IN BETWEEN THE 15TH AND 20TH UNITS ARE FAINT AND NOT FULLY LEGIBLE, SEEMING TO TERMINATE CLOSE TO THE BASE VERTICAL MARKING. CUSTOMER ALSO RETURNED A TOTAL OF (25) 0.3ML SYRINGES WITH NO OTHER IDENTIFICATION. 20 OF THE RETURNED SYRINGES WERE FOUND TO HAVE PLUNGERS THAT WERE DIFFICULT TO MOVE UP AND DOWN THE LENGTH OF THE SYRINGE. 1 WAS THE SYRINGE WITH THE BROKEN PLUNGER ROD IN THE 2ND IMAGE AND WAS NOTED TO ALSO HAVE A PLUNGER THAT WAS DIFFICULT TO MOVE UP AND DOWN. THE REMAINING 3 FEATURED STOPPERS THAT HAD SEPARATED FROM THEIR PLUNGER RODS. THIS ISSUE WILL BE ADDRESSED IN COMPLAINT (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9343317 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE IMAGES RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE SCALE MARKINGS BEING MISALIGNED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE IMPRINT OF UNIT OF MEASURE ARE NOT ACCURATE, FADED, MISSING, ETC. PLUNGERS OVER-SIZED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE IMPRINT OF UNIT OF MEASURE ARE NOT ACCURATE, FADED, MISSING, ETC. PLUNGERS OVER-SIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627406 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown