BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANTEC CONCENTRIC NEEDLE ELECTRODE

    MDR report key: 8678176 · Received June 7, 2019

    Report

    Report Number
    3005581270-2019-00008
    Event Type
    Injury
    Date Received
    June 7, 2019
    Date of Event
    April 24, 2019
    Report Date
    August 2, 2019
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    PMA / PMN Number
    K143433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNS HAVE BEEN REQUESTED , HOWEVER THE CUSTOMER HAS SCRAPPED THE NEEDLE AND THE CABLES. RETAINS AND WORK ORDER RECEIVED. CUSTOMER HAS NOTED THAT THE BELOW INFORMATION IS CONFIDENTIAL AND HAS NOT PROVIDED THIS TO NATUS: A.4 PATIENT WEIGHT. A2 PATIENT AGE. B6 RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES. B7 OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS. THIS ISSUE HAS BEEN PREVIOUSLY INVESTIGATED THROUGH A CAPA003896. CAPA003896 ROOT CAUSE INVESTIGATION SUMMARY: FROM THE ROOT CAUSE INVESTIGATION COMPLETED, ISSUES HAVE BEEN IDENTIFIED WITH: - SUPPLIER NO. 1 : DANTEC COLOUR COVER (CAVITY 3) INTERNAL DIAMETER 4.38 MM +/-0.05 FOUND TO BE ABOVE SPECIFICATION AND INTERNAL DIAMETER 4.48 +/- 0.07 FOUND TO BE BELOW SPECIFICATION. - SUPPLIER NO. 2 : CABLE CONNECTOR 9013C0014 SEPARATION FORCE TO HUB 065Y005/065Y006 FOUND TO BE ABOVE MAXIMUM SPECIFICATION OF 700 GF. THE REMEDIAL / CORRECTIVE ACTIONS APPLIED ARE AS FOLLOWS: SUPPLIER NO. 1: 1. ALL AFFECTED DANTEC COLOUR COVERS IN HOUSE AT GORT ARE TO BE DISPOSITIONED AS "USE AS IS" (NCR015014). THE FOLLOWING ACTIONS (2,3,4 & 5) WILL BE CARRIED OUT ON THE AFFECTED COLOUR COVERS FROM ACTION 1 ABOVE. 2. INCREASED INSPECTION POST SORTIMAT/KOMAX 4 ASSEMBLY FOR HUB TO COLOUR COVER RETENTION TEST UNDER DCO#25362. 3. TIGHTENED ALERT LIMITS TO BE IMPLEMENTED FOR ALL RESULTS UNDER DCO#25362. 4. SCRAP AFFECTED BAGS OF COLOUR COVERS WITH KNOWN HUB RETENTION RESULTS OUTSIDE THE NEWLY ESTABLISHED ALERT LIMITS - NCR015414. 5. HUB RETENTION RESULTS TO BE DOCUMENTED UNDER QMS-003948 DANTEC DCN NEEDLE IN-PROCESS INSPECTION FOR HUB TO COLOUR COVER RETENTION. 6. REVIEW OF TECA CONCENTRIC AND MONOPOLAR TOOLING AT SUPPLIER NO. 1 FOR POTENTIAL, SIMILAR ISSUES. 7. GORT REVALIDATION ASSESSMENT. 8. INACTIVATE QMS-003948 DANTEC DCN NEEDLE IN-PROCESS INSPECTION FOR HUB TO COLOUR COVER RETENTION AND UPDATE RELEVANT PROCEDURES. 9. ALL PARTS RECEIVED FROM SUPPLIER NO. 1 TO BE ROUTED FOR INCOMING INSPECTION. 10. PROCEDURE TO BE CREATED FOR INCOMING INSPECTION OF DANTEC COLOUR COVERS. SUPPLIER NO. 2: 1. NCR016739 WAS INITIATED ON THE (B)(6) 2018, DISPOSITION OF ALL CABLE CONNECTORS CURRENTLY IN HOUSE AT NATUS 2. TMV80 & TMV81 COMPLETED FOR CABLE TO NEEDLE MATING AND SEPARATION FORCE TESTING 3. FIRST ARTICLE INSPECTION COMPLETED FOR ALL INCOMING CABLES 4. ALL PARTS RECEIVED FROM SUPPLIER NO. 2 TO BE ROUTED FOR INCOMING INSPECTION 5. RELEASE OF INCOMING INSPECTION PROCEDURE FOR TESTING OF SUPPLIER NO. 2 CABLES THROUGH DCO#28081 . 6. ECO#28737 TO CORRECT DRAWING DOC-012690 TO CORRECT THE INSERTION AND SEPARATION FORCE FROM 400 - 700 GMS TO 400 - 800 GM. A SCAR HAS BEEN RAISED TO THE SUPPLIER IN RELATION TO THIS ISSUE AND IS DOCUMENTED UNDER CAPA004079. IDENTIFIED ACTIONS OF CAPA003896 WERE DUE TO BE COMPLETED BY THE(B)(6) 2019.AND HAVE BEEN IMPLEMENTED SINCE THE (B)(6) 2019. IDENTIFIED ACTIONS OF CAPA004079 WERE DUE TO BE COMPLETED BY (B)(6) 2019.AND HAVE BEEN COMPLETED ON (B)(6) 2019.

    Additional Manufacturer Narrative · 0

    NATUS ARE WAITING TO RECEIVE INFORMATION REQUESTED IN THE QUESTIONNAIRE BACK FROM THE CUSTOMER. TECHNICAL SERVICE TEAM TO REQUEST THIS INFORMATION AGAIN. WORK ORDER (B)(4) WAS REVIEWED. NO NCR'S RELATED TO THIS LOT. NO REWORKS WERE CARRIED OUT. NO EXCESSIVE SCRAP QUANTITIES NOTED. IN PROCESS TESTING AND INSPECTIONS RECORDED ON (B)(4) REV G WERE REVIEWED. ALL SAMPLES TAKEN FOR TESTS GAVE ACCEPTABLE RESULTS. THE RESULTS FOR HUB TO COVER RETENTION TEST WERE WITHIN SPECIFICATION WHICH IS MINIMUM 1.2KGF. LOWEST VALUE RECORDED WAS 1.805KGF, HIGHEST RECORDED VALUE WAS 6.785KGF. THE FOLLOWING TEST WAS CARRIED OUT ON A QTY OF 5 NEEDLES (RETAINS): HUB TO COVER RETENTION TEST AS PER DOC-011097 REV S - ALL NEEDLES PASSED WITH RESULTS WITHIN MINIMUM SPEC OF 1.2KGF. LOWEST VALUE RECORDED WAS 1.645KGF, HIGHEST RECORDED VALUE WAS 6.250KGF. CUSTOMER HAS BEEN CONTACTED TO PROVIDE THE REST OF THE REQUIRED INFORMATION BELOW AND WE ARE WAITING FOR A RESPONSE: PATIENT IDENTIFIER

    Additional Manufacturer Narrative · 1

    RETURNS HAVE BEEN REQUESTED (REMAINING NEEDLES / CABLE). RETAINS AND WORK ORDER RECEIVED. A QUESTIONNAIRE HAS BEEN SENT TO THE CUSTOMER FOR FURTHER INFORMATION IN RELATION TO THE INCIDENT. CUSTOMER HAS BEEN CONTACTED TO PROVIDE THE REST OF THE REQUIRED INFORMATION BELOW AND WE ARE WAITING FOR A RESPONSE: PATIENT WEIGHT, PATIENT AGE, DATE OF EVENT, RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES, OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS, CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT). RACE AND ETHNICITY: PLEASE NOTE, NATUS HAS BEEN PREVIOUSLY INFORMED THAT IT IS NOT LEGAL TO ASK PATIENT RACE AND PATIENT ETHNICITY IN (B)(6).

    Description of Event or Problem · 1

    HUB TO COLOUR SEPARATION - 9013S0012: ISSUE WITH A NEEDLE AND ITS HUB (THE DOCTOR GOT STUNG WITH THE NEEDLE). "9013S0012 - LOT NUMBER UNKNOWN (LABEL SCRAPPED). AT THE END OF AN EMG TEST, THE NEEDLE HAS BEEN DISCONNECTED FROM THE CABLE BY THE DOCTOR. IN FACT, THE PLASTIC HOLDER HAS DISCONNECTED FROM THE NEEDLE AND ONLY THE HOLDER HAS BEEN REMOVED FROM THE ELECTRODE. THE DOCTOR DID NOT SEE THAT THE NEEDLE REMAINED CONNECTED. HE GOT STUNG WHILE MAKING THE NEXT EMG (A WEEK LATER). THE DOCTOR FOLLOWED THE AES (BLOOD EXPOSURE ACCIDENT) PROCEDURE AND MADE THE STATEMENT AND FOLLOW-UP IN (B)(6) EMERGENCY DEPARTMENT. A STATEMENT WAS MADE TO (B)(6). THE OFFENDING DEVICE IS NOT AVAILABLE FOR EXPERTISE (THROWN)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473703 DANTEC CONCENTRIC NEEDLE ELECTRODE DANTREC DISPOSABLE CONCENTRIC NEEDLE, IKT NATUS MANUFACTURING LIMITED 9013S0012 45C/18/D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other