BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINITUBES

    MDR report key: 6441921 · Received March 29, 2017

    Report

    Report Number
    3002807968-2015-00027
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    May 28, 2015
    Report Date
    February 2, 2016
    Manufacturer
    RADIOMETER MEDICAL APS.
    Product Code
    GIO
    PMA / PMN Number
    EXCEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL CLINITUBE THAT BROKE WAS DISCARDED BY THE CUSTOMER. CLINITUBES FROM THE SAME LOT WERE RETURNED TO AND INVESTIGATED BY RADIOMETER. THE INVESTIGATION OF THE CLINITUBES SHOWED NO DEVIATION OF THE AFFECTED LOT FROM THE EXPECTED QUALITY. IT HAS NOT BEEN POSSIBLE TO ESTABLISH THE ROOT CAUSE OF THIS EVENT. THIS IS A RESUBMISSION OF THE FOLLOW-UP NO 1 MDR, IN WHICH MFR REPORT # WAS INCORRECTLY STATED AS CFN-BASED RATHER THAN FEI-BASED (3002807-2015-000027 RATHER THAN 3002807968-2015-000027).

    Additional Manufacturer Narrative · 1

    THE AFFECTED LOT WILL BE INVESTIGATED UPON RECEIPT AT RADIOMETER MEDICAL APS. ALSO, IT IS BEING INVESTIGATED IF THE STAFF MEMBER CAME IN TO CONTACT WITH PATIENT BLOOD IN RELATION TO THE CUT. THE RESULT OF THIS INVESTIGATION WILL BE INCLUDED IN THE FINAL REPORT. THIS IS A RESUBMISSION OF THE INITIAL MDR, IN WHICH MFR REPORT # WAS INCORRECTLY STATED AS CFN-BASED RATHER THAN FEI-BASED (3002807-2015-000027 RATHER THAN 3002807968-2015-000027). NO FIELDS, IN ADDITION TO MFR REPORT # AND HAVE BEEN CHANGED SINCE THE ORIGINAL SUBMISSION.

    Description of Event or Problem · 1

    NO INFORMATION OF THE CUSTOMER COMING INTO CONTACT HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2015 A CAPILLARY TUBE (CLINITUBE) SNAPPED WHILE A STAFF MEMBER IN A NEONATAL HOSPITAL UNIT WAS TAKING A SAMPLE FROM AN INFANT. WHILE HOLDING THE TUBE TO SAMPLE, THE TUBE SNAPPED IN HALF PIERCING THE GLOVE, CAUSING A CUT AND LEAVING A SHARD OF GLASS IN THE WOUND. THE CUSTOMER REPORTED, THAT THE STAFF MEMBER WAS TRAINED IN THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225113 CLINITUBES CLINITUBES (CAPILLARY TUBES) GIO RADIOMETER MEDICAL APS. D957G-70-100 LV-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S