BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER 19X1-1/2 TW

    MDR report key: 18845812 · Received March 6, 2024

    Report

    Report Number
    1911916-2024-00163
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    January 4, 2024
    Report Date
    July 10, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051060
    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): 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

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS A CLOG. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER AND SIX PHOTOS WERE PROVIDED FOR INVESTIGATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS THEN ASSEMBLED TO A SYRINGE WITH SALINE SOLUTION. IT WAS NOT POSSIBLE TO EXPEL THE SOLUTION; THE NEEDLE IS CLOGGED. IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR WHILE PASSING THE NEEDLE THROUGH THE STOPPER VIAL CLOGGING THE NEEDLE WITH THE STOPPER VIAL MATERIAL. THE PHOTOS SHOW A SYRINGE WITH A NEEDLE ASSEMBLY CONNECTED TO IT AND THE NEEDLE ASSEMBLY WITH THE PLASTIC SHIELD REMOVED. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS SUCH AS A VISION SYSTEM THAT INSPECTS 100% OF ALL PRODUCTS FOR CLOGGED NEEDLES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, LOT 2020895. 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. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THERE WAS A CLOG. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, SIX PHOTOS WERE PROVIDED FOR INVESTIGATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE WITH A NEEDLE ASSEMBLY CONNECTED TO IT AND THE NEEDLE ASSEMBLY WITH THE PLASTIC SHIELD REMOVED. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, LOT 2020895. 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. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. A PHYSICAL SAMPLE WOULD BE REQUIRED TO OFFER A PROBABLE ROOT CAUSE.

    Description of Event or Problem · 0

    MATERIALS#: 305200; BATCH#: 2052538. IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGE WAS NOTED AS BEING "CLOGGED". VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED ON 04JAN2024, REGENERON MEDICAL INFORMATION RECEIVED A RETURN/REPLACEMENT REQUEST FROM (B)(6) ASSOCIATES FOR 1 EYLEA HD VIAL KIT. PER REPORTER, THE SYRINGE WAS NOTED AS BEING "CLOGGED" WHEN THE DOCTOR WAS READY TO INJECT. THE REPORTER DID NOT HAVE ANY ADDITIONAL DETAILS ON WHAT WAS "CLOGGED" AND THE DOCTOR WAS NOT AVAILABLE TO CLARIFY. NO PATIENT MISSED RECEIVING A DOSE OF EYLEA HD DUE TO THIS EVENT. THERE WERE NO ADVERSE EVENTS REPORTED. THE REPORTER WAS REQUESTED TO STORE CARTON AND VIAL KIT FOR RETRIEVAL. THE NEEDLE IS ATTACHED. THE REPORTER ANSWERED UNKNOWN TO QUESTION 7 "WHEN WAS THE DIFFICULTY NOTED:", BECAUSE SHE WAS NOT CERTAIN AND THE DOCTOR WAS UNAVAILABLE TO CLARIFY. BD LOT NUMBER: 2052538; BD CATALOG ITEM NUMBER: 305200.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIALS#: 305106 BATCH#: 2020895. IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGE WAS NOTED AS BEING "CLOGGED". VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED ON 04JAN2024, REGENERON MEDICAL INFORMATION RECEIVED A RETURN/REPLACEMENT REQUEST FROM BOSTON UNIVERSITY EYE ASSOCIATES FOR 1 EYLEA HD VIAL KIT. PER REPORTER, THE SYRINGE WAS NOTED AS BEING "CLOGGED" WHEN THE DOCTOR WAS READY TO INJECT. THE REPORTER DID NOT HAVE ANY ADDITIONAL DETAILS ON WHAT WAS "CLOGGED" AND THE DOCTOR WAS NOT AVAILABLE TO CLARIFY. NO PATIENT MISSED RECEIVING A DOSE OF EYLEA HD DUE TO THIS EVENT. THERE WERE NO ADVERSE EVENTS REPORTED. THE REPORTER WAS REQUESTED TO STORE CARTON AND VIAL KIT FOR RETRIEVAL. THE NEEDLE IS ATTACHED. THE REPORTER ANSWERED UNKNOWN TO QUESTION 7 "WHEN WAS THE DIFFICULTY NOTED:", BECAUSE SHE WAS NOT CERTAIN AND THE DOCTOR WAS UNAVAILABLE TO CLARIFY. BD LOT NUMBER: 2052538. BD CATALOG ITEM NUMBER: 305200.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIALS#: 305106 BATCH#: 2020895. IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGE WAS NOTED AS BEING "CLOGGED". VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ON (B)(6) 2024, REGENERON MEDICAL INFORMATION RECEIVED A RETURN/REPLACEMENT REQUEST FROM (B)(6). FOR 1 EYLEA HD VIAL KIT. PER REPORTER, THE SYRINGE WAS NOTED AS BEING "CLOGGED" WHEN THE DOCTOR WAS READY TO INJECT. THE REPORTER DID NOT HAVE ANY ADDITIONAL DETAILS ON WHAT WAS "CLOGGED" AND THE DOCTOR WAS NOT AVAILABLE TO CLARIFY. NO PATIENT MISSED RECEIVING A DOSE OF EYLEA HD DUE TO THIS EVENT. THERE WERE NO ADVERSE EVENTS REPORTED. THE REPORTER WAS REQUESTED TO STORE CARTON AND VIAL KIT FOR RETRIEVAL. THE NEEDLE IS ATTACHED. THE REPORTER ANSWERED UNKNOWN TO QUESTION 7 "WHEN WAS THE DIFFICULTY NOTED:", BECAUSE SHE WAS NOT CERTAIN AND THE DOCTOR. WAS UNAVAILABLE TO CLARIFY. BD LOT NUMBER: 2052538. BD CATALOG ITEM NUMBER: 305200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670270 NEEDLE FILTER 19X1-1/2 TW NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE FMI BECTON DICKINSON 2020895 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown