BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER-LOK SYRINGE

    MDR report key: 7504926 · Received May 10, 2018

    Report

    Report Number
    1911916-2018-00237
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Date of Event
    May 1, 2018
    Report Date
    September 17, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED TWO 60ML SYRINGES FOR EVALUATION. OUR QUALITY ENGINEER WAS ABLE TO INSPECT THE RETURNED SAMPLES AND NOTICED THAT THERE APPEARED TO HAVE BE DAMAGE ON THE PLUNGER RODS. THE RODS WERE CONFIRMED TO BE BROKEN AND THE ENGINEER WAS ABLE TO VERIFY THE REPORTED ISSUE OF DAMAGE. HOWEVER, THE ENGINEER FAILED TO IDENTIFY ANY INSTANCES OF FOREIGN MATTER, EXCESSIVE LUBRICANT, SCALE MARKING ISSUES OR PACKAGE SEAL INTEGRITY AND WAS UNABLE TO VERIFY ANY OF THE DEFECTS FROM THE TWO RETURNED SAMPLES. DAMAGE TO THE PLUNGER ROD LIKELY OCCURRED DURING THE ASSEMBLY PROCESS. IF THERE WAS ANY MISALIGNMENT IN THE ASSEMBLY OF THE PLUNGER ROD TO THE SYRINGE BARREL, THE MACHINE COULD JAM AND IN THE PROCESS BREAK OR DAMAGE THE PLUNGER ROD. THERE WAS ONE PREVIOUSLY REPORTED ISSUE WITH THE SCALE MARKINGS FOR THIS LOT BUT NO REPORTED ISSUES WITH FOREIGN MATTER, EXCESSIVE LUBRICANT, OR DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED ZERO DEFECTS FOUND DURING PRODUCTION OF THIS LOT. INVESTIGATION CONCLUSION: PLUNGER ROD DAMAGE LIKELY OCCURRED DURING THE ASSEMBLY PROCESS. IF THERE IS ANY MISALIGNMENT IN THE ASSEMBLY OF THE PLUNGER ROD TO THE SYRINGE BARREL, THE MACHINE COULD JAM AND BREAK/DAMAGE THE PLUNGER ROD.

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD¿ LUER-LOK SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER/OTHER/ PACKAGE SEAL INTEGRITY/EPOXY EXCESSIVE. IT WAS STATED ¿THERE WERE THE FOLLOWING COMPLAINTS: PARTICULATE / CONTAMINATION, DAMAGE, EXCESS LUBRICANT, INCLUSIONS.¿ NO FURTHER INFORMATION AVAILABLE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER/OTHER/ PACKAGE SEAL INTEGRITY/EPOXY EXCESSIVE. IT WAS STATED ¿THERE WERE THE FOLLOWING COMPLAINTS: PARTICULATE/CONTAMINATION, DAMAGE, EXCESS LUBRICANT, INCLUSIONS.¿ NO FURTHER INFORMATION AVAILABLE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7170605, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2017-06-19, MEDICAL DEVICE LOT #: 7179894, MEDICAL DEVICE EXPIRATION DATE: 2022-05-31, DEVICE MANUFACTURE DATE: 2017-06-28. DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD¿ LUER-LOK SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER/OTHER/ PACKAGE SEAL INTEGRITY/EPOXY EXCESSIVE. IT WAS STATED ¿THERE WERE THE FOLLOWING COMPLAINTS: PARTICULATE/CONTAMINATION, DAMAGE, EXCESS LUBRICANT, INCLUSIONS.¿ NO FURTHER INFORMATION AVAILABLE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348056 BD¿ LUER-LOK SYRINGE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other