BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17131941 · Received June 14, 2023

    Report

    Report Number
    1920898-2023-00361
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 18, 2023
    Report Date
    August 17, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. E.1. INITIAL REPORTER PHONE #: (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2122806. D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027. H4. DEVICE MANUFACTURE DATE:02-MAY-2022. D4. MEDICAL DEVICE LOT #: 2227420. D4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2027. H4. DEVICE MANUFACTURE DATE: 15-AUG-2022.

    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 5 SHELF CARTONS FROM LOT# 2122806 AND 3 SHELF CARTONS FROM LOT# 2227420 WITH (100) 0.3ML X 31G X 6MM SYRINGES INSIDE, REPORTING SCALE MARKING DEFECTIVE. THE RETURNED SYRINGES WERE VISUALLY EXAMINED AND OBSERVED NO ISSUES. THE (30) SYRINGES FROM EACH LOT WERE INSPECTED VIA GAUGE TO ENSURE CORRECT PLACEMENT OF THE GRADUATION MARKINGS AND OBSERVED THE RETURN SAMPLES FOUND TO BE WITHIN PERMITTED SPECIFICATIONS. FUNCTIONALITY TEST WAS PERFORMED AND OBSERVED NO ISSUES. NO DAMAGE TO THE NEEDLES OF ANY KIND WAS OBSERVED AND ALL FUNCTIONED AS INTENDED. HENCE, THE REPORTED ISSUE COULD NOT BE CONFIRMED BASED ON THE SAMPLES RETURN FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2122806 AND 2227420. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 750 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OF THE 300 COMPENSATION SAMPLES, 268 ARE "IN ACCURATE SCALE MARKS" AS IN PREVIOUS FILINGS. IN ADDITION TO THE COMPENSATION SAMPLE, THE SAME ISSUE OCCURS FOR 500 NEW PRODUCTS PURCHASED BY THE CUSTOMER. THIS IS THE THIRD CASE OF THE SAME CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 750 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OF THE 300 COMPENSATION SAMPLES, 268 ARE "IN ACCURATE SCALE MARKS" AS IN PREVIOUS FILINGS. IN ADDITION TO THE COMPENSATION SAMPLE, THE SAME ISSUE OCCURS FOR 500 NEW PRODUCTS PURCHASED BY THE CUSTOMER. THIS IS THE THIRD CASE OF THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409377 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 SEE H10 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown