BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 23X1-1/2 RB TW

    MDR report key: 19809801 · Received July 23, 2024

    Report

    Report Number
    1911916-2024-00531
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    July 18, 2024
    Report Date
    August 19, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051947
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. LOT 4064579: IT WAS REPORTED THERE IS FOREIGN WRITING ON THE OUTSIDE OF THE CARTON. TO AID IN THE INVESTIGATION, ONE SAMPLE AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE IS A PACKAGING SHELF BOX WITH NO DEFECTS OR IMPERFECTIONS OBSERVED. THE PACKAGING IS CORRECT. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305194, LOT 4064579. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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 AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. LOT 4031270: IT WAS REPORTED THERE IS FOREIGN WRITING ON THE OUTSIDE OF THE CARTON. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A PACKAGING SHELF BOX FROM LOT 4031270. THE BOTTOM FLAP HAS A SECTION IN CHINESE. THE BACK SIDE OF THE BOX, NOT SHOWN, HAS THE SAME INFORMATION IN ENGLISH AND FRENCH. THIS PACKAGING IS CORRECT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305194, LOT 4031270. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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 AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    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 BATCH REPORTED: BATCH: 4064579. BATCH CREATION DATE: 2024-03-04. BATCH EXPIRATION DATE: 2029-04-30.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL# 305194; BATCH# 4064579, #4031270. IT WAS REPORTED BY CUSTOMER THAT THE CARTON HAS FOREIGN WRITING ON THE OUTSIDE OF THE CARTON. VERBATIM: REF# 305194 LOT# 4064579 AND 4031270 THE CARTON HAS FOREIGN WRITING ON THE OUTSIDE OF THE CARTON. CUSTOMER WOULD LIKE TO CONFIRM THAT THIS PRODUCT IS A BD PRODUCT.

    Description of Event or Problem · 0

    MATERIAL# 305194 , BATCH# 4064579 #4031270. IT WAS REPORTED BY CUSTOMER THAT THE CARTON HAS FOREIGN WRITING ON THE OUTSIDE OF THE CARTON. REF# 305194 LOT# 4064579 AND 4031270 THE CARTON HAS FOREIGN WRITING ON THE OUTSIDE OF THE CARTON. CUSTOMER WOULD LIKE TO CONFIRM THAT THIS PRODUCT IS A BD PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483216 NEEDLE 23X1-1/2 RB TW NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4031270 30382903051947

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown