BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 2ML

    MDR report key: 10119570 · Received June 4, 2020

    Report

    Report Number
    3002682307-2020-00182
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    May 14, 2020
    Report Date
    January 12, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 1911242 AND 2001127 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EVALUATION BY OUR QUALITY ENGINEER. THROUGH EXAMINATION OF THE RETAINED SAMPLES, NO DEFECTS WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL?: YES. D10: RETURNED TO MANUFACTURER ON: 1/3/2021. H6: INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 1911242 AND 2001127 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, LEAKAGE WAS OBSERVED, BUT NO SIGNS OF SCALE MARKING DEFECTS WERE IDENTIFIED. TO FURTHER ANALYZE THIS ISSUE, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THROUGH EXAMINATION OF THE RETAINED SAMPLES, NO DEFECTS WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS, IT HAS BEEN DETERMINED THAT PART OF THIS REPORTED ISSUE RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE CAN OCCUR DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING LINE OR DURING THE ASSEMBLY PROCESS. OUR QUALITY TEAM WAS NOT ABLE TO IDENTIFY ANY ISSUES REGARDING SCALE MARKINGS IN EITHER THE RETURNED AFFECTED SAMPLE OR THE RETAINED SAMPLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 2ML LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN THE NEONATAL RESUSCITATION DEPARTMENT, STAFF PURGE THE 1 MM 1.5 M MALE/FEMALE PE/PVC EXTENDER WITH 2 ML SYRINGES. THE NURSE USUALLY PROVIDES 1.5 ML OF PURGE FOR THIS EXTENDER (SO FAR BY PUSHING 1.5 ML THE EXTENDER WAS PURGED AND A SMALL DROP CAME OUT). FOR SOME TIME NOW: THERE WAS MORE LIQUID COMING OUT AFTER THE PURGE. WE TESTED THE SYRINGE'S GRADUATION AND NOTICED A SHIFT IN THE GRADUATION OF THE SYRINGE. ( TESTS MADE WITH 2 SYRINGES OF DIFFERENT BATCHES ).".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 2ML LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN THE NEONATAL RESUSCITATION DEPARTMENT, STAFF PURGE THE 1 MM 1.5 M MALE/FEMALE PE/PVC EXTENDER WITH 2 ML SYRINGES. THE NURSE USUALLY PROVIDES 1.5 ML OF PURGE FOR THIS EXTENDER (SO FAR BY PUSHING 1.5 ML THE EXTENDER WAS PURGED AND A SMALL DROP CAME OUT). FOR SOME TIME NOW: THERE WAS MORE LIQUID COMING OUT AFTER THE PURGE. WE TESTED THE SYRINGE'S GRADUATION AND NOTICED A SHIFT IN THE GRADUATION OF THE SYRINGE. (TESTS MADE WITH 2 SYRINGES OF DIFFERENT BATCHES)."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1911242. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 2001127. MEDICAL DEVICE EXPIRATION DATE: 2024-12-31. DEVICE MANUFACTURE DATE: 2020-01-14. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE S2 2ML LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN THE NEONATAL RESUSCITATION DEPARTMENT, STAFF PURGE THE 1 MM 1.5 M MALE/FEMALE PE/PVC EXTENDER WITH 2 ML SYRINGES. THE NURSE USUALLY PROVIDES 1.5 ML OF PURGE FOR THIS EXTENDER (SO FAR BY PUSHING 1.5 ML THE EXTENDER WAS PURGED AND A SMALL DROP CAME OUT). FOR SOME TIME NOW: THERE WAS MORE LIQUID COMING OUT AFTER THE PURGE. WE TESTED THE SYRINGE'S GRADUATION AND NOTICED A SHIFT IN THE GRADUATION OF THE SYRINGE. ( TESTS MADE WITH 2 SYRINGES OF DIFFERENT BATCHES )."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585577 SYRINGE S2 2ML SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other