BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITACRE SET 27GA 3-1/2IN

    MDR report key: 11901459 · Received May 28, 2021

    Report

    Report Number
    3003152976-2021-00300
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    April 29, 2021
    Report Date
    May 27, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: 6735. INVESTIGATION SUMMARY: TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, THE NEEDLE WAS OBSERVED TO BE BENT; THEREFORE THE REPORTED FAILURE COULD BE VERIFIED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2004005 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES OF THE SAME LOT WERE ALSO USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON ANY OF THE NEEDLES. THE ASSEMBLY OF THE INTRODUCER NEEDLE TO THE CANNULA IS A MANUAL PROCESS AND PERSONNEL ARE TRAINED SPECIFICALLY FOR THIS FUNCTION DUE TO THE CARE REQUIRED WHILE PERFORMING. PRODUCT IS INSPECTED THROUGHOUT THE MANUFACTURING PROCESS ACCORDING TO PROCEDURE, VERIFYING ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION AND THERE IS NO DAMAGE OR DEFECTS WITH THE PRODUCT. ALL RECORDS WERE REVIEWED AND NO ISSUES WERE IDENTIFIED DURING INSPECTIONS FOR THE REPORTED LOT. WHILE WE CANNOT IDENTIFY A DEFINITIVE ROOT CAUSE, IT IS LIKELY THIS INCIDENT IS DUE TO IMPROPER MANIPULATION DURING ASSEMBLY. A PROJECT WAS INITIATED TO REDUCE DAMAGE TO THE PRODUCT WHICH INCLUDES RETAINING ALL PERSONNEL ON PROPER HANDLING AND INSPECTIONS TO BE PERFORMED DURING MANUFACTURING. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE. INVESTIGATION CONCLUSION: DHR OF PACKING LOT 2004005 HAS BEEN REVIEWED AND FOUND NO DEVIATIONS OR NO-CONFORMANCE RELATED TO THE ALLEGED DEFECT. THE DHR OF THE ASSEMBLY SET REF: 1650243STA , LOT: 0090659, HAS BEEN REVIEWED AND FOUND NO DEVIATIONS OR NO-CONFORMANCE RELATED TO THE ALLEGED DEFECT. THE DHRS OF THE INTRODUCERS THAT WERE USED TO FORM THE SET REF. 1650239STA LOTS: 0022882 AND 0023123 HAS BEEN REVIEWED AND FOUND NO DEVIATIONS OR NO-CONFORMANCE RELATED TO THE ALLEGED DEFECT. THE DHR OF THE WHITACRE NEEDLES THAT WERE USED TO FORM THE SET REF: 8367093, LOTS 0058031, 0085012 AND 9322623 HAS BEEN REVIEWED AND FOUND NO DEVIATIONS OR NO-CONFORMANCERELATED TO THE ALLEGED DEFECT. ALL DHRS OF ALL COMPONENTS HAVE BEEN REVIEWED FINDING NO DEVIATIONS OR NONCONFORMITIES RELATED TO THIS EVENT. TWO PICTURES WAS RECEIVED FOR THE INVESTIGATION. THE PACKAGE IS OPENED. IT COULD BE CONFIRMED THAT THE NEEDLE IS BENT. PICTURES RECEIVED BY THE CUSTOMER CONFIRMED THE INCIDENCE. THE NEEDLE IS BENT. FIVE RETAINED SAMPLES WERE RECEIVED ON MAY 10, 2021. THEY ARE VISUALLY INSPECTED AND FOUND NO BENT NEEDLES OR OTHER DEFECTS RELATED TO THE COMPLAINT. THE POTENTIAL EFFECT OF (NEEDLE BENT) APPEARED TO BE MISSING IN PROCESS FMEA.ECR NUMBER 500000203562 WAS CREATED IN SAP SYSTEM TO CREATE FMEA ASSEMBLY PROCESS SPINAL NEEDLE SET + INTRODUCER INCLUDING THE POTENTIAL EFFECT REPORTED (NEEDLE BENT). THE HUB OF THE INTRODUCER HUB IS NOT ATTACHED TO THE CANNULA. THIS FACT MAKES EASIER THAT THE NEEDLE GETS BENT. PERSONNEL IN THE AREA IS SPECIFICALLY TRAINED TO PERFORM THIS OPERATION. NO NON-CONFORMANCES THAT COULD BE RELATED TO THE EVENT REPORTED WERE FOUND DURING DHR REVIEW A WRONG MANIPULATION DURING INTRODUCER ASSEMBLY PROCESS AND PACKAGING IS A POTENTIAL ROOT CAUSE. NEVERTHELESS, SINCE NO ISSUES WERE FOUND DURING, DHR REVIEW NO ROOT CAUSE CAN BE CONFIRMED. INSPECTIONS FOR CANNULAS AT INCOMING ARE PERFORMED ACCORDING TO FR-013. VISUAL INSPECTION IS PERFORMED TO EVALUATE AMONG OTHER DEFECTS BENT CANNULA (AQL 0.25%). DURING ASSEMBLY PROCESS, BETWEEN THE CANNULA AND STYLET SEVERAL INSPECTIONS ARE CARRIED OUT ACCORDING TO AE-301(CURRENT VERSION) TO AVOID DEFECTS IN SPINAL NEEDLES. IT IS CHECKED THAT THE STILETTO IS EASY TO REMOVE FROM THE CANNULA AND THAT THE SPINAL NEEDLE HAS NO DEFECTS (NICKS, PARTICLES, BENT TIPS, ETC). SPINAL NEEDLES ARE EVALUATED WITH A 10X BINOCULAR. CANNULA AND STYLET ALREADY ASSEMBLED ARE MANUALLY ASSEMBLED WITH THE INTRODUCTORY HUB (ACCORDING TO AE-013 CURRENT VERSION). THIS OPERATION IS PERFORMED WITH EXTREMELY CARE AS THE INTRODUCTORY HUB IS NOT ATTACHED TO THE CANNULA. DURING THIS PROCESS, THE OPERATOR NOTICES POSSIBLE DEFECTS IN THE SPINAL NEEDLES. FAULTY SPINAL NEEDLES ARE DISCARDED. PACKING INSPECTIONS: IN PROCESS INSPECTION IS PERFORMED ACCORDING TO AE-303/AE-012 (CURRENT VERSION): PACKING: ONE STRIP OF PRODUCT PER 4 BAGS (4,000 NEEDLES APROX.) IS CHECKED TO VERIFY: CORRECT PRODUCT PACKAGING, PRODUCT FREE OF DAMAGES AND DIRT, ETC... PACKAGING: DURING THE PACKAGING PROCESS OF THE PRODUCT, 100% VISUAL INSPECTION OF THE PRODUCT IS PERFORMED BY THE OPERATOR. ON THE OTHER HAND, UNIT CASE INSPECTION (25 SPINAL NEEDLES) IS PERFORMED FOR EACH TWO ROWS AND AT THE END OF THE PALLET/LOT ACCORDING TO AE-012. IN CASE OF FAULTY PART, THE OPERATOR: REMOVES THE DEFECTED PRODUCT. IN CASE OF MORE THAN 2 DEFECTS/ 50 SAMPLES, THE PACKING OPERATOR HAS TO BE INFORMED. IF THE DEFECT PERSISTS, THE LEADER TEAM OR PROCESS INSPECTOR HAS TO BE AWARE. NO MAINTENANCE INTERVENTIONS THAT COULD BE RELATED TO THE INCIDENCE REPORTED ¿BENT NEEDLE¿ TOOK PLACE IN PROCESS. THE HUB OF THE INTRODUCER HUB IS NOT ATTACHED TO THE CANNULA. THIS FACT MAKES EASIER THAT THE NEEDLE GETS BENT. PERSONNEL IN THE AREA IS SPECIFICALLY TRAINED TO PERFORM THIS OPERATION. NO NON-CONFORMANCES THAT COULD BE RELATED TO THE EVENT REPORTED WERE FOUND DURING DHR REVIEW A WRONG MANIPULATION DURING INTRODUCER ASSEMBLY PROCESS AND PACKAGING IS A POTENTIAL ROOT CAUSE. NEVERTHELESS, SINCE NO ISSUES WERE FOUND DURING, DHR REVIEW NO ROOT CAUSE CAN BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHITACRE SET 27GA 3-1/2IN EXPERIENCED A DAMAGED NEEDLE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE NEEDLE WAS UNWRAPPED IT WAS COMPLETELY BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800693 WHITACRE SET 27GA 3-1/2IN INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON, S.A. 2004005

    Patients

    Seq Age Sex Outcome Treatment
    1