BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE PLASTIPAK 20ML LL S/SU

    MDR report key: 8579412 · Received May 3, 2019

    Report

    Report Number
    3003916417-2019-00221
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    April 23, 2019
    Report Date
    June 18, 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

    A BATCH HISTORY ANALYSIS WAS PERFORMED, QUALITY NOTIFICATIONS AND MAINTENANCE RECORDS WERE VERIFIED WHERE NO RECORDS RELATED TO FAILURE WERE FOUND. THE SAMPLE PROVIDED OF BATCH 8289583 FOR EVALUATION WAS POSSIBLE TO OBSERVE THE INCIDENT. 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. CAPA#944254 WAS INITIATED. THE SAMPLES RELATED TO THE BATCH 8225769 DON¿T SHOW ANY DEFECT. THIS WAY IT WAS NOT POSSIBLE CONFIRM THE OCCURRENCE TO THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE SYRINGE PLASTIPAK 20ML LL S/SU THE SYRINGE IS NOT PROPERLY THREADED IN THE INTRODUCERS, IT IS DIFFICULT TO ATTACH THE SYRINGE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THE SYRINGE IS NOT PROPERLY THREADED IN THE INTRODUCERS, IT IS DIFFICULT TO ATTACH THE SYRINGE. CUSTOMER INFORMED TWO POSSIBLE BATCHES INVOLVED: 8289583 E 8225769. CONSIDER BOTH IN THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8289583; MEDICAL DEVICE EXPIRATION DATE: 2023-10-31; DEVICE MANUFACTURE DATE: 2018-10-16; MEDICAL DEVICE LOT #: 8225769; MEDICAL DEVICE EXPIRATION DATE: 2023-08-31; DEVICE MANUFACTURE DATE: 2018-08-13. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE SYRINGE PLASTIPAK 20ML LL S/SU THE SYRINGE IS NOT PROPERLY THREADED IN THE INTRODUCERS, IT IS DIFFICULT TO ATTACH THE SYRINGE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE SYRINGE IS NOT PROPERLY THREADED IN THE INTRODUCERS, IT IS DIFFICULT TO ATTACH THE SYRINGE. CUSTOMER INFORMED TWO POSSIBLE BATCHES INVOLVED: 8289583 E 8225769. CONSIDER BOTH IN THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372495 SYRINGE PLASTIPAK 20ML LL S/SU SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other