BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50ML LL CLEAR 14GA 1-1/4IN

    MDR report key: 10008171 · Received April 28, 2020

    Report

    Report Number
    3002682307-2020-00137
    Event Type
    Malfunction
    Date Received
    April 28, 2020
    Date of Event
    April 8, 2020
    Report Date
    May 26, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 1903279, 1904243, 1904242, AND 1903258, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF EACH LOT WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, THE STOPPER WAS PROPERLY ASSEMBLED ONTO THE PLUNGER AND NO LEAK WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURS PAST THE STOPPER WITH A BD SYRINGE 50ML LL CLEAR 14GA 1-1/4IN. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE WITH BATCH # 1903279 AND 1903258, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: TTHE RECURRENT INCIDENCE THAT WE ARE HAVING WITH SYRINGES FOR USE IN PREPARING CYTOSTATICS, AND WHERE DIFFERENT MEDICATIONS HAVE BEEN IMPLICATED. THE PROBLEM CONTINUES AS SOME FAIL. IT IS NOT A SINGLE BATCH, BUT WE HAVE BEEN ABLE TO VERIFY THE FAILURE IN DIFFERENT BATCHES. IN ALL CASES, THE PROBLEM IS THE SAME: THE CONTENT OF THE SYRINGE LEAKS OUT THE BACK OF THE PLUNGER, LEADING TO A SPILL AND LOSS OF MEDICATION. IN MANY CASES IT HAS INVOLVED THE PRODUCTION OF THE PREPARATION AGAIN SINCE IT IS NOT POSSIBLE TO CALCULATE THE PART LOST IN THE SPILL. MOST OF THE TIME IT HAS INVOLVED THE 50CC SYRINGE, ALTHOUGH OTHER SIZES LIKE THE 1ML ONE HAVE ALSO BEEN AFFECTED. IT SHOULD BE SAID THAT THIS IS ONLY A SAMPLING OF CASES, SINCE THERE HAVE REALLY BEEN MORE CASES THAN WE CAN REPORT HERE.

    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 #: 1903279. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-04-01. MEDICAL DEVICE LOT #: 1904243. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-04-03. MEDICAL DEVICE LOT #: 1904242. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-04-01. MEDICAL DEVICE LOT #: 1903258. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-03-27. " 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 THAT LEAKAGE OCCURS PAST THE STOPPER WITH A BD SYRINGE 50ML LL CLEAR 14GA 1-1/4IN. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE WITH BATCH # 1903279 AND 1903258, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE RECURRENT INCIDENCE THAT WE ARE HAVING WITH SYRINGES FOR USE IN PREPARING CYTOSTATICS, AND WHERE DIFFERENT MEDICATIONS HAVE BEEN IMPLICATED. THE PROBLEM CONTINUES AS SOME FAIL. IT IS NOT A SINGLE BATCH, BUT WE HAVE BEEN ABLE TO VERIFY THE FAILURE IN DIFFERENT BATCHES. IN ALL CASES, THE PROBLEM IS THE SAME: THE CONTENT OF THE SYRINGE LEAKS OUT THE BACK OF THE PLUNGER, LEADING TO A SPILL AND LOSS OF MEDICATION. IN MANY CASES IT HAS INVOLVED THE PRODUCTION OF THE PREPARATION AGAIN SINCE IT IS NOT POSSIBLE TO CALCULATE THE PART LOST IN THE SPILL. MOST OF THE TIME IT HAS INVOLVED THE 50CC SYRINGE, ALTHOUGH OTHER SIZES LIKE THE 1ML ONE HAVE ALSO BEEN AFFECTED. IT SHOULD BE SAID THAT THIS IS ONLY A SAMPLING OF CASES, SINCE THERE HAVE REALLY BEEN MORE CASES THAN WE CAN REPORT HERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471830 BD SYRINGE 50ML LL CLEAR 14GA 1-1/4IN PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other