BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL ¿SECONDARY SET C61 WITH A BUILT-IN PHASEAL¿ CONNECTOR

    MDR report key: 7337863 · Received March 14, 2018

    Report

    Report Number
    2243072-2018-00126
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    February 14, 2018
    Report Date
    June 22, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    PMA / PMN Number
    K972527
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED. DHR REVIEW SHOWED NO NCR-S PRESENT THAT COULD POTENTIALLY EXPLAIN THE ISSUE COSTUMER WAS DESCRIBING. DHR OF THE LOT CONTAINS RESULTS OF THE FUNCTIONAL TESTING ON THE PRODUCT WHICH WAS INTRODUCED AFTER RESTART OF PRODUCTION ON (B)(6) 2017. TRAINING RECORD OF ALL OPERATORS INVOLVED IN PRODUCTION OF THIS LOT AND DISPENSER CHECKUP, AFTER START OF EACH NEW LOT OF THE C61 SECONDARY SET THE DISPENSERS ARE CHECKED FOR FUNCTIONALITY OF ALL PARTS. NO FURTHER INFORMATION WAS GIVEN FROM THE COSTUMER REGARDING THE CIRCUMSTANCES THAT LEAKAGE OCCURRED, DESCRIPTION OF C35 LEAKING FROM SPIKE WOULD BE IMPOSSIBLE AS STATED IN INVESTIGATION. ASSUMPTION THAT COSTUMER WAS ACTUALLY DESCRIBING LEAKAGE ON 6096 PHASEAL AND SPIKE 5328 WAS TAKEN AS BASE OF INVESTIGATION. AFTER INVESTIGATION NO POTENTIAL ROOT CAUSE COULD BE DETERMINATE IF NEW INFORMATION ARRIVES REGARDING THESE COMPLAINTS INVESTIGATION CAN BE REOPENED. C35 CONNECTOR COSTUMER WAS DESCRIBING IS NOT A PART OF C61 SYSTEM/PRODUCT. PHASEAL CONNECTOR ON C61 SYSTEM IS 6096 AND IT SHARES SOME RESEMBLANCE WITH C35 LUER LOCK. OHR FOR LOT 1005467 CONTAINS RESULTS OF FUNCTIONAL TESTING PER ISO 8536, 750 SAMPLES ARE TAKEN EVENLY FROM LOT TO TEST FOR AIR LEAKAGE AND RESULT S ARE CONFORMING. OHR ALSO SHOWS REDUCED FINISHED GOOD QUANTITY FROM (B)(4), THIS IS DUE TO MATERIAL SHORTAGE AND BECAUSE OF THIS TIME TO PRODUCE THE LOT WAS PROLONGED. DISPENSER THAT WAS USED IN THIS PHASE IS ION 346 BUSHING C DUE TO SPECIFIC NATURE OF JOINT THIS DISPENSER IS ONLY USED FOR THIS JOINT. ON (B)(6) 2017 PREVENTIVE MAINTENANCE WAS PERFORMED ON THIS DISPENSER WITHOUT ANY REPLACEMENTS AND WAS CHECKED AGAIN PRIOR TO LOT START (B)(6) 2017.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FAILURE DESCRIPTION: LEAKAGE AT THE C35 CONNECTOR ON THE SPIKE REFERENCE PR284637, 284689, & 284675 PRODUCT 515302, LOT 1005467 BACKGROUND: DHR REVIEW SHOWED NO NCR'S PRESENT THAT COULD POTENTIALLY EXPLAIN ISSUE CUSTOMER WAS DESCRIBING. DHR OF THE LOT CONTAINS RESULTS OF THE FUNCTIONAL TESTING ON THE PRODUCT WHICH WAS INTRODUCED AFTER RESTART OF PRODUCTION ON (B)(6) 2017. TRAINING RECORD OF ALL OPERATORS INVOLVED IN PRODUCTION OF THIS LOT AND DISPENSER CHECKUP, AFTER START OF EACH NEW LOT OF THE C61 SECONDARY SET, THE DISPENSERS ARE CHECKED FOR FUNCTIONALITY OF ALL PARTS. DETAILED EXPLANATION IN DEVIATION MEMO WHICH IS ALSO INCLUDED IN DHR. INVESTIGATION CONCLUSIONS: C35 CONNECTOR CUSTOMER IS DESCRIBING IS NOT A PART F C61 SYSTEM/PRODUCT. PHASEAL CONNECTOR ON C61 SYSTEM IS 6096 AND SHARES SOME RESEMBLANCE WITH C35 LUER LOCK DHR FOR LOT 1005467 CONTAINS RESULTS OF FUNCTIONAL TESTING PER ISO 8536, 750 SAMPLES ARE TAKEN EVENLY FROM LOT TO TEST FOR AIR LEAKAGE AND RESULTS AND CONFORMING. DHR ALSO SHOWED REDUCED FINISHED GOOD QUANTITY, THIS IS DUE TO MATERIAL SHORTAGE AND BECAUSE OF THIS TIME TO PRODUCE THE LOT WAS PROLONGED. DISPENSER THAT WAS USED IN THIS PHASE IS IDN 346 BUSING C DUE TO SPECIFIC NATURE OF JOIN THIS DISPENSER IS ONLY USED FOR THIS JOINT. (B)(6) 2017 PREVENTIVE MAINTENANCE WAS PERFORMED ON THIS DISPENSER WITHOUT ANY REPLACEMENTS AND WAS CHECKED AGAIN PRIOR TO LOT START ON (B)(6) 2017. INVESTIGATION CONCLUSION: MATERIAL: DURING TESTING ON SITE, TEST FOR LEAKAGE WOULD DETECT THIS LACK OF TOLERANCE AS LEAKAGE (OUT OF TOLERANCE PHASEAL CONNECTOR) METHOD: PROCEDURE DESCRIBES THE CORRECT WAY OF ASSEMBLY. MACHINE: UNLIKELY - DISPENSER MALFUNCTION - DISPENSER CHECK UP AT START OF EVERY LOT AND AFTER PAUSES ON THE SAME LOT BY MAINTENANCE OPERATORS. ROOT CAUSE: NO FURTHER INFORMATION WAS GIVEN FROM THE CUSTOMER REGARDING THE CIRCUMSTANCES THAT LEAKAGE OCCURRED, DESCRIPTION OF THE C35 LEAKING FROM THE SPIKE WOULD BE IMPOSSIBLE AS STATED IN INVESTIGATION. ASSUMPTION THAT CUSTOMER WAS ACTUALLY DESCRIBING LEAKAGE ON 3096 PHASEAL AND SPIKE 5328 WAS TAKEN AS BASE OF INVESTIGATION. AFTER INVESTIGATION NO POTENTIAL ROOT CAUSE COULD BE DETERMINED. IF NEW INFORMATION ARRIVES REGARDING THESE COMPLAINTS, INVESTIGATION CAN BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. 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 A BD PHASEAL ¿SECONDARY SET C61 WITH A BUILT-IN PHASEAL¿ CONNECTOR LEAKED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182793 BD PHASEAL ¿SECONDARY SET C61 WITH A BUILT-IN PHASEAL¿ CONNECTOR CONNECTOR LHI BECTON DICKINSON 1005467

    Patients

    Seq Age Sex Outcome Treatment
    1 Other