BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2 5ML

    MDR report key: 8976104 · Received September 9, 2019

    Report

    Report Number
    3002682307-2019-00492
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    August 23, 2019
    Report Date
    October 24, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH TWO SAMPLES AND A PHOTO FOR CATALOG 309050 LOTS 1903143 AND 1905204 TO INVESTIGATE FOR THIS RECORD. THE EVALUATION OF THE RETURNED SAMPLES DID NOT PRESENT ANY ISSUES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. THE EVALUATION OF THE PROVIDED PICTURE SHOWS A PLASTIC PARTICLE OF THE PLUNGER IN THE SYRINGE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD HAS CONCLUDED THAT THE PLASTIC PIECE WAS PRODUCED IN THE ASSEMBLY MACHINE IN THE PLUNGER ASSEMBLY PROCESS. CONCLUSION: THE INCORRECT ALIGNMENT OF THE PLUNGER IN THIS PROCESS PRODUCED THE DAMAGE IN THE PLUNGER AND THE PLASTIC PARTICLE, WHICH ENDED INSIDE THE SYRINGE. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED ATTACHED TO THE PLUNGER WITH A BD SYRINGE S2 5ML. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM GERMAN TO ENGLISH: A SOLID PARTICLE WAS FOUND IN A BD 5 ML SYRINGE (DISCARDIT II MADE IN SPAIN REF 309050). IT SEEMS TO BE A PLASTIC THREAD ATTACHED TO THE PLUNGER SINCE IT MOVES UP AND DOWN ALONG WITH THE PLUNGER. IT IS DANGEROUS FOR THE PATIENT IF THE PLASTIC THREAD SEPARATES FROM THE PLUNGER AN ENTERS THE BLOODSTREAM.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1905204. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-05-06. MEDICAL DEVICE LOT #: 1903143. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-02-27. " 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 PRIOR TO USE FOREIGN MATTER WAS DISCOVERED ATTACHED TO THE PLUNGER WITH A BD SYRINGE S2 5 ML. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM (B)(6) TO ENGLISH: A SOLID PARTICLE WAS FOUND IN A BD 5 ML SYRINGE (DISCARDIT II MADE IN SPAIN REF 309050). IT SEEMS TO BE A PLASTIC THREAD ATTACHED TO THE PLUNGER SINCE IT MOVES UP AND DOWN ALONG WITH THE PLUNGER. IT IS DANGEROUS FOR THE PATIENT IF THE PLASTIC THREAD SEPARATES FROM THE PLUNGER AN ENTERS THE BLOODSTREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770210 BD SYRINGE S2 5ML SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other