BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 8185783 · Received December 20, 2018

    Report

    Report Number
    2243072-2018-01841
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 8, 2018
    Report Date
    February 20, 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
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IN SECTION H.10 OF THE PREVIOUSLY SUBMITTED MDR, SECTIONS D.1 AND H.1 WERE INCORRECTLY REFERENCED AS THE MEDICAL DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THOSE REFERENCES TO SHOW THE FOLLOWING: D.4 MEDICAL DEVICE EXPIRATION DATE H.4 DEVICE MANUFACTURE DATE. H.6. INVESTIGATION SUMARY: IT HAS BEEN RECEIVED 2 PICTURES FOR INVESTIGATION. UPON VISUAL INSPECTION OF THESE TWO PICTURES IT CAN BE OBSERVED THAT THE SYRINGE TIP IS BROKEN BY OVER-SCREW AND THE BROKEN TIP REMAINED ATTACHED TO THE FEMALE PART LUER LOK. IT WAS SCREWED UNTIL IT RESULTED DETACHED. DHR OF LOT 1810231 AND 1809251 HAS BEEN REVIEWED FINDING AN ANNOTATION REGARDING THE ALLEGED DEFECT. TIP AND THREAD VERIFICATION IS PERFORMED IN THE FIRST LOT MANUFACTURED PER MANUFACTURING LINE IN THE MONTH WITH ISO594 PASS/NON PASS GAUGES (#10-419/1 AND #10-413 RESPECTIVELY) ACCORDING TO PROCEDURES PC-132, PC-133 AND JG-600. ACCORDING TO INSPECTION PLAN PROCEDURE JG-500, 200 UNITS ARE INSPECTED EVERY 2 PALLETS BY QUALITY CONTROL TEAM. IN ADDITION, FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED BY OPERATOR AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES (JG-301, JG-302, JG-303 AND JG-304): 1. VISUAL INSPECTION MOLDING: 2 INJECTIONS PER SHIFT PRINTING: 32 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. ASSEMBLY: 32 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. PRIMARY PACKAGING: 1 ADVANCE-STEP (WITHOUT PRODUCT) PER HOUR, AFTER ANY INTERVENTION IN THE EQUIPMENT, AND ONCE AT THE BEGINNING OF THE SHIFT. SECONDARY PACKAGING: 1 SHELF-PACKAGE PER PALLET. 2. FUNCTIONAL INSPECTION PRINTING: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT. ASSEMBLY: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT. PRIMARY PACKAGING: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT. SINCE NO ISSUES WERE IDENTIFIED AND MANUFACTURING RECORD ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, AND ACCORDING TO PICTURES RECEIVED IT CAN BE CONFIRMED THIS DEFECT HAS BEEN CAUSED BY CUSTOMER DUE TO OVER-SCREW.

    Additional Manufacturer Narrative · 0

    CORRECTION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A BD PLASTIPAK¿ SYRINGE WAS BROKEN DURING USE AND A PART OF IT IS STUCK IN THE FEMALE PART LUER LOCK. MEDICAL DEVICE BRAND NAME: BD PLASTIPAK¿ SYRINGE. MEDICAL DEVICE TYPE: N/A. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON, S.A. MANUFACTURING LOCATION: BECTON DICKINSON, S.A. PMA / 510(K)#: N/A. MEDICAL DEVICE CATALOG #: 300865. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1810231, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: 2018-10-16. MEDICAL DEVICE LOT #: 1809251, MEDICAL DEVICE EXPIRATION DATE: 2023-08-31, DEVICE MANUFACTURE DATE: 2018-09-28. UNIQUE IDENTIFIER (UDI) # : (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT HAS BEEN RECEIVED 1 USED SAMPLE OF 50LL WITHOUT BLISTER FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE SAMPLE IT CAN BE OBSERVED THAT THE SYRINGE TIP IS BROKEN BY OVER-SCREW AND THE BROKEN TIP REMAINED ATTACHED TO THE FEMALE PART LUER LOK. IT WAS SCREWED UNTIL IT RESULTED DETACHED. DHR OF LOT 1810231 AND 1809251 HAS BEEN REVIEWED FINDING AN ANNOTATION REGARDING THE ALLEGED DEFECT. SINCE NO ISSUES WERE IDENTIFIED AND MANUFACTURING RECORD ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, AND ACCORDING TO SAMPLE RECEIVED IT CAN BE CONFIRMED THIS DEFECT HAS BEEN CAUSED BY CUSTOMER DUE TO OVER-SCREW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PLASTIPAK¿ SYRINGE WAS BROKEN DURING USE AND A PART OF IT IS STUCK IN THE FEMALE PART LUER LOCK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PLASTIPAK¿ SYRINGE WAS BROKEN DURING USE AND A PART OF IT IS STUCK IN THE FEMALE PART LUER LOCK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED BD¿ SYRINGE WAS BROKEN DURING USE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS UNKNOWN. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4)., AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 AN UNSPECIFIED BD¿ SYRINGE WAS BROKEN DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024769 BD PLASTIPAK¿ SYRINGE SYPRINGE FMF BECTON DICKINSON, S.A. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other