BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17076044 · Received June 6, 2023

    Report

    Report Number
    1920898-2023-00338
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 15, 2023
    Report Date
    August 31, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2143234. MEDICAL DEVICE EXPIRATION DATE: 30JUN2027. DEVICE MANUFACTURE DATE: 23MAY2022. MEDICAL DEVICE LOT #: 1347417. MEDICAL DEVICE EXPIRATION DATE: 31DEC2026. DEVICE MANUFACTURE DATE: 13DEC2021. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 09-JUN-2023 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED 8 OPEN POLYBAGS WITH SYRINGES FROM LOT2143234, 8 OPEN POLYBAGS FROM LOT1242719 AND 4 OPEN POLYBAGS FROM LOT 1347417. CUSTOMER STATED THAT CLEAR AND TRANSPARENT LIQUID IS FOUND INSIDE THE SYRINGE. THE RETUNED SYRINGES WERE VISUAL INSPECTED, AND NO LIQUID WAS VISUALLY OBSERVED. THEN 10 SYRINGES FROM EACH LOT WERE TESTED BY PUSHING THE PLUNGER ROD AND SMALL DROPS OF CLEAR LIQUID CAME OUT FROM: 2 SYRINGES FROM LOT 1242719, 3 SYRINGES FROM LOT 2143234, AND 4 SYRINGES FROM LOT1347417. THE MATERIAL WAS REMOVED AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE FTIR RESULT WAS THE SAME FOR ALL LOTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 1242719, 1347417, AND 2143234 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER INDICATED ISSUE. ROOT CAUSE ANALYSIS: AN FTIR TEST WAS PERFORMED TO VERIFY THE LIQUID REPORTED BY THE CUSTOMER. THE RESULT OF THE FTIR CONCLUDES THE MATERIAL BEING A MEDICAL GRADE SILICONE, WHICH IS USED AS A MATERIAL IN OUR PROCESS TO EXERCISE THE SMOOTH MOVEMENT OF A PLUNGER IN THE SYRINGE. SINCE ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS, A DEFINITIVE ROOT-CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE FOREIGN MATTER WAS FOUND. THIS OCCURRED 588 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THAT CLEAR AND TRANSPARENT LIQUID IS FOUND INSIDE THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE FOREIGN MATTER WAS FOUND. THIS OCCURRED 588 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THAT CLEAR AND TRANSPARENT LIQUID IS FOUND INSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093593 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 1242719 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown