BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 21899015 · Received April 24, 2025

    Report

    Report Number
    1911916-2025-00301
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    April 10, 2025
    Report Date
    April 29, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    K941562
    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

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE VIAL OPENED AND ACCESSED WITH A BLUNT FILL NEEDLE RESULTED IN A PINK-TINGED DRUG PRODUCT IN THE MEDICATION VIAL AND IN DRAWN UP SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH TWO OPENED PACKAGING BLISTERS AND FIVE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH 30X MAGNIFICATION. THERE WAS NO DAMAGE, DEFECTIVE GRIND OR HOOKS OBSERVED. THE BEVELS AND ETCH WERE GOOD. THE SAMPLE WAS THEN ASSEMBLED TO A SYRINGE WITH SALINE SOLUTION. THE SOLUTION WAS EXPELLED INTO A GLASS; NO ISSUES WERE OBSERVED. THE FIVE PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED AND A VIAL. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305180, LOT 4270208. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL # 305180, LOT # 4270208. IT WAS REPORTED BY CUSTOMER THAT VIAL OPENED AND ACCESSED WITH A BLUNT FILL NEEDLE RESULTED IN A PINK-TINGED DRUG PRODUCT IN THE MEDICATION VIAL AND IN DRAWN UP SYRINGE. NEEDLE HAS COLORED PARTICULATE MATTER DEPOSITS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I WOULD LIKE TO REPORT A POTENTIAL PRODUCT QUALITY ISSUE. DETAILS OF THE QUALITY ISSUE EXPERIENCED PREVIOUSLY UNOPENED HYDRALAZINE VIAL OPENED AND ACCESSED WITH A BLUNT FILL NEEDLE RESULTED IN A PINK-TINGED DRUG PRODUCT IN THE MEDICATION VIAL AND IN DRAWN UP SYRINGE. NEEDLE HAS COLORED PARTICULTE MATTER DEPOSITS. UNCLEAR IF DISCOLORATION IS RELATED TO MEDICATION, NEEDLE, OR AN INTERACTION BETWEEN THE TWO MATERIALS. MEDICATION INFORMATION: HYDRALAZINE 20MG/ML 1ML VIAL NDC 63323-614-21, LOT: 6133530, EXPIRATION DATE: 2026/04.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273884 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 4270208 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown