BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18 G X 1.25 IN. (1.3 MM X 31 MM) BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 6884944 · Received September 21, 2017

    Report

    Report Number
    1710034-2017-00203
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    August 29, 2017
    Report Date
    October 19, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K111366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: PR #: (B)(4), PART #: 383511 - 18G X 1.25IN HF Y, LOT #: 7011597, COMPLAINT: LEAKAGE AT SEPTUM (NEXIVA), EVENT DESCRIPTION: BLOOD LEAKED INTO BACK OF CATHETER UPON INSERTION. LOT ANALYSIS: DEVICE/BATCH HISTORY RECORD REVIEW: YES. REASON: DHRS ARE AVAILABLE FOR REVIEW AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE. THIS COMPLAINT IS CLASSIFIED AS MDR. FINDINGS: A QN ((B)(4)) WAS INITIATED DURING ITS PRODUCTION FOR AIR/WATER LEAK TEST FAILURE (SEPTUM). ALL CHALLENGES WERE SUCCESSFUL AND NO QUALITY RELATED FINDINGS WERE DISCOVERED SET-UP AND IN PROCESS SAMPLES INCLUDING (BUT NOT LIMITED TO) CANNULA CORRECTLY INSERTED THROUGH SEPTUM, CORRECT ASSEMBLY, AND AIR-WATER LEAK TEST ALL PASSED PER SPECIFICATION. SAP-QN DATABASE REVIEW: YES. REASON: DHR WAS REVIEWED. FINDINGS: FOUND 2 NON-RELATED QN¿S ((B)(4)) AND 1 RELATED QN ((B)(4) AIR/WATER LEAK TEST FAILURE) (SEPTUM)). PEURA (END USER RISK ANALYSIS) REVIEW: YES. REASON: A REVIEW OF THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: BASED ON THE PROVIDED VERBATIM, THE EFFECT OF THE REPORTED FAILURE IS BLOOD LEAKAGE THAT DID NOT REQUIRE MEDICAL INTERVENTION. PER (B)(4), THIS EFFECT HAS A LIMITED SEVERITY RANKING OF S2. THIS IS THE FIRST COMPLAINT FOR LEAKAGE ON THIS BATCH, AND THE OCCURRENCE IS LOW. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: RECEIVED ONE 18GA USED UNIT CONSISTING ON AN EXTENSION SET CONNECTED TO A BD VACUTAINER AND A MALE LUER, A FULLY RETRACTED NEEDLE-GRIP ASSEMBLY, A PIECE OF TOP WEB (PACKAGING) FROM LOT NUMBER 7011597 AND A MISCELLANEOUS BOTTOM FILM (PACKAGING). VISUAL/MICROSCOPIC EXAMINATION: THE UNIT HAD TRACES OF PATIENT RESIDUE (BLOOD) ON THE EXTENSION SET, THE CATHETER TUBING AND WITHIN THE UNIT, TRACES OF LEAKAGE WAS OBSERVED AROUND THE CANISTER AND THE SEPTUM. NOTE: THE UNIT WAS SOAKED OVERNIGHT INTO WATER/BLEACH SOLUTION IN AN ATTEMPT TO REMOVE THE DRY BLOOD AND PERFORM THE WATER LEAK TEST. OCCLUSION (BLOOD) COULD NOT BE REMOVED. WATER/AIR LEAK TEST: WATER/AIR LEAK TEST WAS PERFORMED BY CONNECTING THE END OF THE LAB SUPPLIED MALE SLIP LUER TEST FITTING TO THE ADAPTER. ALTHOUGH NO LEAKAGE WAS OBSERVED THE UNIT WAS SEVERELY OCCLUDED NOT ALLOWING THE AIR TO PASS THROUGH THE UNIT. NOTE: THE UNIT WAS DISSECTED AND THE SEPTUM WAS MICROSCOPICALLY OBSERVED, THE UNIT REVEALED THE TOP OF THE SEPTUM HAD BEEN PIERCED (CORING OF THE PRIMARY SEPTUM) BY THE CANNULA. THE SLIT WAS PRESENT PER SPECIFICATION. TEST DESCRIPTION METHOD NO RESULTS VISUAL/MICROSCOPIC N/A. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO. THE UNIT REVEALED THE TOP OF THE SEPTUM HAD BEEN PIERCED (CORING OF THE PRIMARY SEPTUM) BY THE CANNULA. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? YES, ALTHOUGH THE UNIT DID NOT LEAK DURING THE PERFORMANCE OF THE WATER LEAK TEST THE CONDITION OF THE SEPTUM TOP (CORED) CONFIRMED THE CUSTOMER¿S EXPERIENCE OF LEAKING AT SEPTUM WITH THE BD PRODUCT. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO, LEAKAGE COULD NOT BE REPRODUCED DURING THE PERFORMANCE OF THE WATER LEAK TEST PERFORMED IN THE LABORATORY ENVIRONMENT. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. COMMENT: THE DEFECT DESCRIBED IN THE INCIDENT REPORT WAS CONFIRMED BUT COULD NOT BE REPRODUCED. THIS ISSUE WAS IDENTIFIED DURING THE PRODUCTION OF THIS LOT. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED AS THE STATION WAS ALIGNED AND SAMPLING DID NOT FIND ANY DEFECTS. THE DAMAGE TO THE SEPTUM, AS OBSERVED DURING THE DISSECTION AND MICROSCOPIC EVALUATION, CAN OCCUR DURING ASSEMBLY WHEN THE CANNULA BACKEND IS INSERTED THROUGH A SLIT IN THE SEPTUM. HOWEVER, DURING THE INVESTIGATION, NOTHING ABOUT THE PROCESS WAS IDENTIFIED AS A ROOT CAUSE. PROJECT (B)(4) REDESIGNED THE CANNULA AND SEPTUM WHICH CHANGED THE INSERTION PROCESS. THE CHANGE IN THE PROCESS IS EXPECTED TO REDUCE THE OCCURRENCE OF THIS DEFECT. CORRECTIVE ACTION PROJECT / CAPA (#): PROJECT (B)(4) WAS INITIATED TO ADDRESS LEAKAGE DUE TO THIS TYPE OF DAMAGE TO THE SEPTUM. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME. OTHER ACTIONS TAKEN: PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND/OR PROCESS CONTROL TECHNICIANS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKED BACK INTO AN 18 G X 1.25 IN. (1.3 MM X 31 MM) BD NEXIVA¿ CLOSED IV CATHETER SYSTEM UPON INSERTION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662501 18 G X 1.25 IN. (1.3 MM X 31 MM) BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7011597

    Patients

    Seq Age Sex Outcome Treatment
    1 Other