CLINITUBES

Additional Manufacturer Narrative

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).

Description of Event or Problem

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

Additional Manufacturer Narrative

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

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.