BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8441030 · Received March 21, 2019

    Report

    Report Number
    3003152976-2019-00217
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    March 5, 2019
    Report Date
    March 11, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). INVESTIGATION SUMMARY: ONE PHOTO SAMPLE WAS PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A HAIR WAS OBSERVED INSIDE THE SYRINGE. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 1812224 THAT MAY HAVE CONTRIBUTED TO THE REPORTED INCIDENT. OUR PRODUCT IS MANUFACTURED IN A STANDARD CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER IN THE PRODUCT. ALL INDIVIDUALS ARE REQUIRED TO FOLLOW PROPER GOWNING PROCEDURES BEFORE ENTERING THE ROOM, INCLUDING HAIR PROTECTION. IT WAS DETERMINED THIS INCIDENT OCCURRED AS A RESULT OF IMPROPER GOWNING MY MANUFACTURING PERSONNEL. WE HAVE NOTIFIED OUR MANUFACTURING STAFF TO BRING BETTER AWARENESS TO THIS ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE WITH THE PHOTO SAMPLE PROVIDED. 1 PICTURE WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION OF THIS PICTURE, A HAIR CAN BE OBSERVED INSIDE THE SYRINGE. DHR OF LOT 1812224 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. MANUFACTURING AREA FOR 50LL SYRINGES IS A STANDARD CLEAN AREA ISO9 WHICH IS UNDER A POSITIVE PRESSURE TO PUSH DUST AND PARTICLES OUT OF THE MANUFACTURING AREA. OPERATORS WEAR PROTECTIVE CLOTHES (HAIR-COVES, MOUSTACHE-COVER, COAT, BEARD-COVER, SHOES-COVER) ACCORDING TO INTERNAL PROCEDURE ((B)(4)). THIS DEFECT HAS BEEN CAUSED BECAUSE OPERATOR DOES NOT FOLLOW THE CLOTHING RULES ACCORDING TO PROCEDURE (B)(4). DE-IONIZER AND BLOWING SYSTEM EXIST IN ASSEMBLY STATION TO REDUCE FOREIGN MATTER INSIDE THE SYRINGE. ACCORDING TO INSPECTION PLAN PROCEDURE (B)(4), 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 ((B)(4)): 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 TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT, AND ONCE AT THE BEGINNING OF THE SHIFT. SECONDARY PACKAGING: 1 SHELF-PACKAGE PER PALLET. 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. ALTHOUGH NO ISSUES WERE IDENTIFIED AND MANUFACTURING RECORD STABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, WE CAN CONFIRM THAT THE ROOT CAUSE OF THE NON-CONFORMANCE IS RELATED WITH HUMAN ERROR. THE ROOT CAUSE IS THAT OPERATOR DOES NOT FOLLOW THE CLOTHING RULES ACCORDING TO PROCEDURE. QUALITY PROJECT#(B)(4) IS OPEN TO REDUCE THIS FOREIGN MATTER IN THIS PRODUCT. IN ORDER TO REINFORCE OUR CUSTOMER SATISFACTION, WE WOULD LIKE TO INFORM YOU THAT OUR MANUFACTURING FACILITY WAS ALERTED OF YOUR EXPERIENCE. ROOT CAUSE DESCRIPTION: OPERATOR DOES NOT FOLLOW THE CLOTHING RULES ACCORDING TO PROCEDURE (B)(4). RATIONALE: PROJECT#(B)(4) ISSUED TO REDUCE FM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAIR WAS NOTICED INSIDE THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WHILE DRAWING UP CYTOTOXIC MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DURING DRAWING OF A CYTOTOXIC DRUG, A HAIR WAS SPOTTED INSIDE THE SYRINGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234749 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1812224

    Patients

    Seq Age Sex Outcome Treatment
    1 Other