SAFECLINITUBES
Received Jan 3, 2012 · Event occurred Oct 21, 2011
Report 3002807968-2011-00020 · MDR key 2427385
Device
Product problems
- Detachment Of Device Component
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
THE CAPILLARY END CAPS CAME OFF THE TUBE DURING TRANSPORT, CAUSING THE BLOOD SAMPLE TO BE WASTED. THE USER HAD TO STICK THE PT AGAIN IN ORDER TO RESAMPLE.
Additional Manufacturer Narrative
THE TYPICAL FAILURE MODES FOR THE END CAPS IS EITHER LEAKAGE BECAUSE THE END CAPS FALL OF DURING TRANSPORT IN PNEUMATIC TUBES (LOOSE FIT) OR BREAKING OF GLASS CAPILLARY TUBES WHEN MOUNTING THE END CAPS (TIGHT FIT). THE END CAPS INNER DIAMETER WERE NARROWED FROM LOT 1037508 AFTER A THOROUGH REVIEW OF THE PRODUCT THROUGH POST MARKETING SURVEILLANCE. AFTER THIS CUSTOMER'S INITIAL COMPLAINT IN (B)(6) 2011 THEIR STOCK WAS REPLACED BY A NEWER LOT OF END CAPS. THERE HAVE BEEN NO FURTHER COMPLAINTS FROM THIS CUSTOMER.
Remedial action
- Replace