BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPACK¿ SYRINGE

    MDR report key: 7059504 · Received November 27, 2017

    Report

    Report Number
    2243072-2017-00311
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 30, 2017
    Report Date
    December 13, 2017
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: INVESTIGATION WAS PERFORMED FOR CATALOGUE 990172, LOT NUMBER 7081533 AND THE MANUFACTURING DATE FOR THIS BATCH WAS MARCH 30-31, 2017. LOT NUMBER HISTORY REVIEW, DHR REVIEW AND BATCH RECORDS WERE OBSERVED. THIS IS THE FIRST COMPLAINT FOR HIS BATCH ON THIS INCIDENT, THERE WERE NO QUALITY NOTIFICATION, MAINTENANCE OR OTHER DEVIATION FOUND FOR THIS BATCH. EVALUATING THE SAMPLE PROVIDED BY THE CUSTOMER, IT IS POSSIBLE TO IDENTIFY THE DEFECT, BARREL CRACKED. THE POTENTIAL CAUSES FOR THE PROBLEM IS BARREL JAM ON FEEDER SYSTEM OR MISALIGNMENT AT ASSEMBLY MACHINE. THAT JAM IS INHERENT TO THE MANUFACTURING PROCESS. BASED ON SAMPLE /PHOTO, THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION LOT NUMBER HISTORY REVIEW / DHR REVIEW: FIRST COMPLAINT FOR THE INCIDENT IN THIS BATCH. IT WAS VERIFIED THE BATCH RECORD AND IT WAS OBSERVED THAT THE MANUFACTURING DATE FOR THIS BATCH WAS MARCH 30-31 2017. NO QUALITY NOTIFICATION, MAINTENANCE OR OTHER DEVIATION WAS FOUND FOR THIS BATCH. CONCLUSION: EVALUATING THE SAMPLE PROVIDED BY THE CUSTOMER, IT IS POSSIBLE IDENTIFY BARREL CRACKED. THE POTENTIAL CAUSES FOR THE PROBLEM IS BARREL JAM ON FEEDER SYSTEM OR MISALIGNMENT AT ASSEMBLY MACHINE. THAT JAM IS INHERENT TO THE MANUFACTURING PROCESS. THE DEFECT IDENTIFIED FROM THIS COMPLAINT WILL BE MONITORED FOR TREND EVALUATION ROOT CAUSE DESCRIPTION: PROBABLE CAUSES: DURING THE PRODUCTION OF THE BATCH NO RECORDS OF OCCURRENCES RELATED TO THIS DEFECT ARE OBSERVED, HOWEVER AFTER THE ANALYSIS OF THE SAMPLES IT IS POSSIBLE CONFIRM BARREL CRACKED. BASED ON THIS EVALUATION THE POTENTIAL CAUSES FOR THE PROBLEM IS: SYRINGE JAM AT FEEDER SYSTEM. MISALIGNMENT AT ASSEMBLY MACHINE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS MDR REPORTABLE. IT WAS REPORTED THAT A BD PLASTIPACK¿ SYRINGE WAS FOUND DURING USE CRACKED AND LEAKING. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841224 BD PLASTIPACK¿ SYRINGE HYPODERMIC SYRINGE FMF BECTON DICKINSON 7081533

    Patients

    Seq Age Sex Outcome Treatment
    1 Other