BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAEMOLANCE PLUS MAX FLOW

    MDR report key: 5965631 · Received September 21, 2016

    Report

    Report Number
    9613304-2016-00001
    Event Type
    Injury
    Date Received
    September 21, 2016
    Date of Event
    July 27, 2016
    Report Date
    February 21, 2018
    Manufacturer
    HTL-STREFA S.A.
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BECAUSE OF LACK OF REPORTED CUSTOMER'S SAMPLE, THE ANALYSIS WAS CARRIED OUT ON THE ARCHIVAL SAMPLE OF THE BATCH NUMBER (V45H12567), WHICH WAS EXAMINED REGARDING THE PARAMETERS INCLUDED IN THE PRODUCT SPECIFICATION ZN-2008/HTL- 420.01 ISSUE 13. ALL LANCETS ACTIVATED PROPERLY, AFTER WHICH THE NEEDLE RETRACTED AS SPECIFIED. EVERY PRODUCED BATCH NUMBER UNDERGOES FINAL EXAMINATION IN QCD REGARDING COMPLIANCE WITH PRODUCT SPECIFICATION PARAMETERS. EXAMINED PARAMETERS FROM THE PRODUCT SPECIFICATION INCLUDE: PRECISION OF PUNCTURE - TEST BASED ON ACTIVATING THE LANCET ON SILICONE CUBE, 1.2 MM THICK, IMITATING THE SKIN'S THICKNESS AND CONFIRMING THE PRESENCE OF THE PUNCTURE ON THE FOIL. RETRACTING OF THE NEEDLE AFTER ACTIVATING - AFTER ACTIVATING THE NEEDLE SHOULD RETRACT AND NOT PROTRUDE FROM THE MOULD. NO NONCONFORMITIES WERE FOUND THAT COULD CONTRIBUTE TO OCCURRENCE OF THE REPORTED FAULT - THE PRODUCT IN COMPLIANCE WITH ITS SPECIFICATIONS. DEVICE HISTORY RECORD ENTRIES WERE CHECKED, NO ENTRIES CONFIRMING THE REPORTED FAULT WERE FOUND. IN CONNECTION WITH LACK OF FAULT CONFIRMATION IN THE ARCHIVAL SAMPLE, AS WELL AS LACK OF THE CUSTOMER'S SAMPLE, IT IS IMPOSSIBLE TO ANALYSE THE REASONS OF THE REPORTED FAULT. HOWEVER, THE COMPANY REMAINS IN TOUCH WITH THE CUSTOMER - ON 2016-08-22 WE RECEIVED MAIL FROM PROSPECT DIAGNOSTICS LIMITED' CUSTOMER INFORMING THAT THE PERSONNEL OF THE CLINIC WHERE THE PATIENT'S BLOOD WAS DRAWN CONTACTED HER AND SENT ADDITIONAL SURVEY IN ORDER TO LEARN ABOUT THE PATIENT'S HEALTH. IN CASE OF RECEIVING THE CUSTOMER'S SAMPLE OR ADDITIONAL IMPORTANT INFORMATION, THE SAMPLE ANALYSIS WILL BE PERFORMED, AND THEN THE REPORT WILL BE REVISED INCLUDING THE RESULTS OF THE AFOREMENTIONED ANALYSIS. (B)(4). IT IS TO BE NOTED THAT THE TYPE OF USED LANCET SHOULD BE ADAPTED INDIVIDUALLY TO A PATIENT AS THE DEEPER THE PUNCTURE, THE BIGGER RISK OF IRRITATION OF THE BLOOD VESSELS AND NERVE ENDINGS. THE DEPTH OF THE PUNCTURE SHOULD BE DIMINISHED AND ITS EFFICIENCY CHECKED. ADDITIONALLY, DURING THE PUNCTURE THE LANCET SHOULD BE PURPOSIVELY PRESSED TO THE SKIN WHICH HELPS THE LANCET TO ENTER THE SKIN. DEPENDING ON THE SKIN THICKNESS WHICH IS AN INDIVIDUAL FEATURE, THE DEPTH OF THE PUNCTURE SHOULD BE DIFFERENTIATED SO THAT THE PROPER AMOUNT OF BLOOD WAS DRAWN WITHOUT TOO MUCH PAIN. WITH REGARD TO THE ABOVEMENTIONED REASONS HTL-STREFA (B)(4). DOES NOT TAKE ANY ACTION REGARDING THE PRESENT COMPLAINT. AS OF 2017-02-20, AN ENVELOPE WITH 11 LANCETS WITHOUT IDENTIFICATION WAS DELIVERED FROM CUSTOMER - WITHOUT IDENTIFICATION. TESTING WAS CONDUCTED FOR COMPLIANCE WITH THE PARAMETERS ESTABLISHED IN PRODUCT SPECIFICATIONS ZN-2008/HTL- 420.01, REV. 13. THE DEFECT UNDER COMPLAINT WAS NOT CONFIRMED IN THE SAMPLE FROM THE CUSTOMER - THE PRODUCT MEETS THE REQUIREMENTS OF SPECIFICATIONS. ADDITIONALLY, NEEDLE POINT QUALITY WAS VISUALLY INSPECTED AT ZOOM X10 - NO DEFECTS WERE OBSERVED WHICH COULD CAUSE THE DEFECT UNDER COMPLAINT. NEEDLE PROTRUSION LENGTH WAS INSPECTED - ALL THE NEEDLES ARE WITHIN THE LIMITS OF SPECIFICATIONS (8,8 ±0,2 MM). THE MEASURED PROTRUSION LENGTH WAS WITHIN 8,60 ÷ 9,00 MM. THE RESULTS OF THE TESTS ABOVE INDICATE THAT THE LANCETS PERFORM AS INTENDED AND THAT THE PENETRATION DEPTH MEETS THE REQUIREMENTS OF PRODUCT SPECIFICATIONS (1,6 ±0,4MM).

    Description of Event or Problem · 0

    THE PATIENT'S FINGER IS NUMB AFTER DRAWING BLOOD WITH HAEMOLANCE. GENERAL PRACTITIONER CLAIMS THAT IT IS NERVE DAMAGE THAT MIGHT BE, BUT NOT NECESSARILY, PERMANENT.

    Additional Manufacturer Narrative · 1

    BECAUSE OF LACK OF REPORTED CUSTOMER'S SAMPLE, THE ANALYSIS WAS CARRIED OUT ON THE ARCHIVAL SAMPLE OF THE BATCH NUMBER ((B)(4)), WHICH WAS EXAMINED REGARDING THE PARAMETERS INCLUDED IN THE PRODUCT SPECIFICATION (B)(4) ISSUE 13. ALL LANCETS ACTIVATED PROPERLY, AFTER WHICH THE NEEDLE RETRACTED AS SPECIFIED. EVERY PRODUCED BATCH NUMBER UNDERGOES FINAL EXAMINATION IN QCD REGARDING COMPLIANCE WITH PRODUCT SPECIFICATION PARAMETERS. EXAMINED PARAMETERS FROM THE PRODUCT SPECIFICATION INCLUDE: PRECISION OF PUNCTURE: TEST BASED ON ACTIVATING THE LANCET ON SILICONE CUBE, 1.2 MM THICK, IMITATING THE SKIN'S THICKNESS AND CONFIRMING THE PRESENCE OF THE PUNCTURE ON THE FOIL. RETRACTING OF THE NEEDLE AFTER ACTIVATING; AFTER ACTIVATING THE NEEDLE SHOULD RETRACT AND NOT PROTRUDE FROM THE MOULD. NO NONCONFORMITIES WERE FOUND THAT COULD CONTRIBUTE TO OCCURRENCE OF THE REPORTED FAULT; THE PRODUCT IN COMPLIANCE WITH ITS SPECIFICATIONS. DEVICE HISTORY RECORD ENTRIES WERE CHECKED, NO ENTRIES CONFIRMING THE REPORTED FAULT WERE FOUND. IN CONNECTION WITH LACK OF FAULT CONFIRMATION IN THE ARCHIVAL SAMPLE, AS WELL AS LACK OF THE CUSTOMER'S SAMPLE, IT IS IMPOSSIBLE TO ANALYSE THE REASONS OF THE REPORTED FAULT. HOWEVER, THE COMPANY REMAINS IN TOUCH WITH THE CUSTOMER - ON 2016-08-22 WE RECEIVED MAIL FROM PROSPECT DIAGNOSTICS LIMITED' CUSTOMER INFORMING THAT THE PERSONNEL OF THE CLINIC WHERE THE PATIENT'S BLOOD WAS DRAWN CONTACTED HER AND SENT ADDITIONAL SURVEY IN ORDER TO LEARN ABOUT THE PATIENT'S HEALTH. IN CASE OF RECEIVING THE CUSTOMER'S SAMPLE OR ADDITIONAL IMPORTANT INFORMATION, THE SAMPLE ANALYSIS WILL BE PERFORMED, AND THEN THE REPORT WILL BE REVISED INCLUDING THE RESULTS OF THE AFOREMENTIONED ANALYSIS. SINCE 2008 ROKU HTL-STREFA (B)(4) HAS SOLD (B)(4) PCS. OF SAFETY LANCETS TYPE 420, AND THIS IS THE FIRST COMPLAINT OF THIS KIND (NUMB FINGER AFTER PROBABLE NERVE DAMAGE) IN THE HISTORY OF COMPLAINTS MADE TO HTL-STREFA (B)(4). IT IS TO BE NOTED THAT THE TYPE OF USED LANCET SHOULD BE ADAPTED INDIVIDUALLY TO A PATIENT AS THE DEEPER THE PUNCTURE, THE BIGGER RISK OF IRRITATION OF THE BLOOD VESSELS AND NERVE ENDINGS. THE DEPTH OF THE PUNCTURE SHOULD BE DIMINISHED AND ITS EFFICIENCY CHECKED. ADDITIONALLY, DURING THE PUNCTURE THE LANCET SHOULD BE PURPOSIVELY PRESSED TO THE SKIN WHICH HELPS THE LANCET TO ENTER THE SKIN. DEPENDING ON THE SKIN THICKNESS WHICH IS AN INDIVIDUAL FEATURE, THE DEPTH OF THE PUNCTURE SHOULD BE DIFFERENTIATED SO THAT THE PROPER AMOUNT OF BLOOD WAS DRAWN WITHOUT TOO MUCH PAIN. WITH REGARD TO THE ABOVEMENTIONED REASONS HTL-STREFA (B)(4) DOES NOT TAKE ANY ACTION REGARDING THE PRESENT COMPLAINT.

    Description of Event or Problem · 1

    THE PATIENT'S FINGER IS NUMB AFTER DRAWING BLOOD WITH HAEMOLANCE. GENERAL PRACTITIONER CLAIMS THAT IT IS NERVE DAMAGE THAT MIGHT BE, BUT NOT NECESSARILY, PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617836 HAEMOLANCE PLUS MAX FLOW FMK FMK HTL-STREFA S.A. N/A V45H12567

    Patients

    Seq Age Sex Outcome Treatment
    1