BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 15850340 · Received November 23, 2022

    Report

    Report Number
    2243072-2022-02036
    Event Type
    Malfunction
    Date Received
    November 23, 2022
    Date of Event
    August 5, 2021
    Report Date
    January 10, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHILE USING THE BD LUER-LOK¿ SYRINGE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE SANITARY SURVEILLANCE SERVICE OF GOVERNMENT DID A RESEARCH IN THEIR OWN NOTIFICATION SYSTEM BETWEEN 01/01/2019 AND 04/14/2022 FOR THE REGIONAL MFG, WHICH IT WAS VERIFIED [...] ON 08/05/2021 FOREIGN MATTER IN THE SYRINGE. D1: MEDICAL DEVICE BRAND NAME: BD LUER-LOK¿ SYRINGE, D4: UDI # (B)(4), D4: CATALOG # 307859, D4: MEDICAL DEVICE LOT #: 0133567, D4: MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025, H4: DEVICE MANUFACTURE DATE: 12-MAY-2020, G.5. PMA / 510(K)#: NA. H6: INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING AN UNSPECIFIED BD SYRINGE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE SANITARY SURVEILLANCE SERVICE OF GOVERNMENT DID A RESEARCH IN THEIR OWN NOTIFICATION SYSTEM BETWEEN 01/01/2019 AND 04/14/2022 FOR THE REGIONAL MFG, WHICH IT WAS VERIFIED ON 08/05/2021. FOREIGN MATTER IN THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD LUER-LOK¿ SYRINGE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE SANITARY SURVEILLANCE SERVICE OF GOVERNMENT DID A RESEARCH IN THEIR OWN NOTIFICATION SYSTEM BETWEEN 01/01/2019 AND 04/14/2022 FOR THE REGIONAL MFG, WHICH IT WAS VERIFIED [...] ON 08/05/2021 FOREIGN MATTER IN THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING AN UNSPECIFIED BD SYRINGE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE SANITARY SURVEILLANCE SERVICE OF GOVERNMENT DID A RESEARCH IN THEIR OWN NOTIFICATION SYSTEM BETWEEN (B)(6) 2019 AND (B)(6) 2022 FOR THE REGIONAL MFG, WHICH IT WAS VERIFIED [...] ON (B)(6) 2021 FOREIGN MATTER IN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291593 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 0133567

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown