MalfunctionGJE
ANGEL WING 23G BCS W/LUER ADPTR
Received Apr 4, 2013
Report 1282497-2013-00008 · MDR key 3063935
Device
Generic name
Blood Collection Device
Manufacturer
CovidienModel number
8881225307Catalog number
8881225307
Lot number
122920027
Product problems
- Detachment Of Device Component
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A BLOOD COLLECTION DEVICE. THE CUSTOMER REPORTS THE METAL NEEDLE GUARD POPPED OFF WHEN THE CLINICIAN MOVED THE GUARD UP TO CAP AT THE END OF THE NEEDLE AFTER THE CLINICIAN DREW BLOOD. THE CUSTOMER ALSO STATED THAT THERE WAS NO MEDICAL INTERVENTION NEEDED AS A RESULT.
Additional Manufacturer Narrative
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.