BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 19722485 · Received July 11, 2024

    Report

    Report Number
    1911916-2024-00491
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    July 5, 2024
    Report Date
    July 16, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: IT WAS REPORTED THERE WAS DIRT ON THE NEEDLE. AS A SAMPLE WAS NOT RETURNED, A THROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A NEEDLE WITH A PARTICLE ATTACHED TO IT. THE PARTICLE APPEARS TO BE FROM THE LUBRICANT APPLIED TO THE OUTER SURFACE OF THE NEEDLE. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211, LOT 3031678. 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 IS CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    WE RECEIVED A COMPLAINT WITH THE FOLLOWING DESCRIPTION: ¿IN THE EMAIL, THE DOCTOR INFORMS THE PJP (PATIENT JOURNEY PARTNER) THAT IN 2 PACKAGES OF VABYSMO BATCH NO: B1542B10 WERE DISCOVERED (IN THE INTACT PACKAGING OF THE TRANSFER NEEDLES, AFTER REMOVING THE PLASTIC COVER) DIRT ON THE NEEDLES. THE DOCTOR TOOK A PICTURE OF THE NEEDLE WITH A MOBILE PHONE AND UNDER A MICROSCOPE (SEE BELOW) THESE NEEDLES WERE NOT USED. THE DOCTOR USED OTHER NEEDLES.¿ HARM TO THE PATIENT NOT REPORTED. FOR THE INVESTIGATION, PLEASE: 1 REVIEW THE BATCH DOCUMENTATION FOR THE AFFECTED NEEDLE BATCH, IN REGARDS TO FOREIGN MATTER DEFECTS ATTACHED TO THE CANNULA. 2 INSPECT THE PHOTOGRAPHS SHOWING THE DEFECT AND ASSESS THE PHOTOS IN REGARDS TO THE UNDERLYING PROCESS, I.E. NEEDLE MANUFACTURING AND DEVICE ASSEMBLY. REPORT ANY OBSERVATION THAT COULD BE IN CORRELATION WITH THE GIVEN COMPLAINT. 3 REPORT ANY DEVIATIONS, EVENTS OR CHANGES THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. 4 PROVIDE A CONCLUSION CONCERNING COMPLAINT EVALUATION (CONFIRMED/NOT CONFIRMED), PLUS ROOT CAUSE AND CAPA IF APPLICABLE. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR RETURN. WE APPRECIATE YOUR SUPPORT ON THE INVESTIGATION BY PROVIDING THE REPORT LATEST ON 27.07.2024.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED WE RECEIVED A COMPLAINT WITH THE FOLLOWING DESCRIPTION: ¿IN THE EMAIL, THE DOCTOR INFORMS THE PJP (PATIENT JOURNEY PARTNER) THAT IN 2 PACKAGES OF VABYSMO BATCH NO: B1542B10 WERE DISCOVERED (IN THE INTACT PACKAGING OF THE TRANSFER NEEDLES, AFTER REMOVING THE PLASTIC COVER) DIRT ON THE NEEDLES. THE DOCTOR TOOK A PICTURE OF THE NEEDLE WITH A MOBILE PHONE AND UNDER A MICROSCOPE THESE NEEDLES WERE NOT USED. THE DOCTOR USED OTHER NEEDLES.¿ HARM TO THE PATIENT NOT REPORTED FURTHER DETAILS CONCERNING PATIENT SUCH AS DEMOGRAPHIC INFO, INITIALS, AGE, GENDER ARE UNKNOWN FOR THE INVESTIGATION, PLEASE: 1 REVIEW THE BATCH DOCUMENTATION FOR THE AFFECTED NEEDLE BATCH, IN REGARD TO FOREIGN MATTER DEFECTS ATTACHED TO THE CANNULA. 2 INSPECT THE PHOTOGRAPHS SHOWING THE DEFECT AND ASSESS THE PHOTOS IN REGARDS TO THE UNDERLYING PROCESS, I.E. NEEDLE MANUFACTURING AND DEVICE ASSEMBLY. REPORT ANY OBSERVATION THAT COULD BE IN CORRELATION WITH THE GIVEN COMPLAINT. 3 REPORT ANY DEVIATIONS, EVENTS OR CHANGES THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. 4 PROVIDE A CONCLUSION CONCERNING COMPLAINT EVALUATION (CONFIRMED/NOT CONFIRMED), PLUS ROOT CAUSE AND CAPA IF APPLICABLE. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR RETURN. WE APPRECIATE YOUR SUPPORT ON THE INVESTIGATION BY PROVIDING THE REPORT LATEST ON 27.07.2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426329 NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 3031678 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown