BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 20ML LL S/SU

    MDR report key: 8753818 · Received July 2, 2019

    Report

    Report Number
    3003916417-2019-00314
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 13, 2019
    Report Date
    August 20, 2019
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: DHR, MAINTENANCE RECORD ANALYSIS AND QUALITY NOTIFICATION ANALYSIS WERE PERFORMED AND NO DEVIATION WAS FOUND FOR THIS BATCH. NO SAMPLES / PHOTOS WERE SENT BY THE CUSTOMER NOT BEING POSSIBLE PERFORMING AN INVESTIGATION AND DETERMINE THE ROOT CAUSE FOR THE INCIDENT. THE MANUFACTURING PROCESS ARE VALIDATED WITH DEFINED ACCEPTANCE CRITERIA. FROM THESE INFORMATION¿S IT IS NOT POSSIBLE CONFIRM THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: DHR, MAINTENANCE RECORD ANALYSIS AND QUALITY NOTIFICATION ANALYSIS WERE REVIEWED AND NO DEVIATION WAS FOUND FOR THIS BATCH. NO SAMPLES / PHOTOS WERE SENT BY THE CUSTOMER FOR EVALUATION. WHEN THE RETENTION SAMPLES WERE EVALUATED, IT WAS POSSIBLE TO VERIFY THE NON-CONFORMITY. WE EVALUATED THE PRESS AND THE MOLD AND WE FOUND OUT A GAP IN THE MOLD RACK ASSEMBLY (DEVICE USED TO EXTRACT THE NOZZLE FROM THE SYRINGE). THE PROBLEM WAS CORRECTED BY REPLACING THE SCREW WHICH WAS CAUSING THE CLEARANCE IN THE RACK ASSEMBLY ACCORDING TO MAINTENANCE ORDER. CAPA 944254 WAS OPENED TO INVESTIGATE FURTHER. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THERE WAS LEAKAGE PAST THE STOPPER WITH A BD SYRINGE PLASTIPAK 20ML LL S/SU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: SYRINGE WITH DIFFICULT TO ATTACH, PRESENTING LEAKAGE. VISUALLY IS POSSIBLE TO OBSERVE THAT THE STOPPER OF THE SYRINGE IS DEFECTIVE. QUANTITY USED MORE THAN 30 NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THERE WAS LEAKAGE PAST THE STOPPER WITH A BD SYRINGE PLASTIPAK 20ML LL S/SU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: SYRINGE WITH DIFFICULT TO ATTACH, PRESENTING LEAKAGE. VISUALLY IS POSSIBLE TO OBSERVE THAT THE STOPPER OF THE SYRINGE IS DEFECTIVE. QUANTITY USED MORE THAN (B)(4) NEEDLES.

    Additional Manufacturer Narrative · 1

    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 DURING USE THERE WAS LEAKAGE PAST THE STOPPER WITH A BD SYRINGE PLASTIPAK 20 ML LL S/SU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: SYRINGE WITH DIFFICULT TO ATTACH, PRESENTING LEAKAGE. VISUALLY IS POSSIBLE TO OBSERVE THAT THE STOPPER OF THE SYRINGE IS DEFECTIVE. QUANTITY USED: MORE THAN 30 NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545925 BD SYRINGE PLASTIPAK 20ML LL S/SU SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 9016814

    Patients

    Seq Age Sex Outcome Treatment
    1 Other