MalfunctionGJE
ANGEL WING 23G BCS W/LUER ADPTR
Received Jan 15, 2014 · Event occurred Jan 9, 2014
Report 1282497-2014-00005 · MDR key 3793208
Device
Generic name
Blood Collection Set
Manufacturer
CovidienModel number
8881225307Catalog number
8881225307
Lot number
132770093X
Product problems
- Material Fragmentation
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A BLOOD COLLECTION SET. THE CUSTOMER REPORTS UPON REMOVAL OF THE BUTTERFLY FROM THE PT'S ARM, THE NEEDLE SEPARATED FROM THE BUTTERFLY AND WAS LEFT IN PT. THE NEEDLE WAS REMOVED FROM THE PT AND NO FURTHER TREATMENT WAS NECESSARY.
Additional Manufacturer Narrative
(B)(4) 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.