ANG WNG 23G BCS W/LUER ATR X50
Received Jul 18, 2014
Report 1282497-2014-00043 · MDR key 4010054
Device
Generic name
Blood Collection Set
Manufacturer
CovidienModel number
8881225307Catalog number
8881225307
Lot number
132490198X
Product problems
- Detachment Of Device Component
- Fluid/Blood Leak
- Connection Problem
- Fail-Safe Problem
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.
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 STATES THAT DURING A BLOOD DRAW, BLOOD STARTED TO LEAK FROM THE NEEDLE AND TUBING CONNECTION WHERE THE BUTTERFLY SAFETY SHIELD IS LOCATED. AT THE END OF THE BLOOD DRAW, THE NEEDLE DISCONNECTED FROM TUBING. THE NEEDLE, WHERE THE LEAK OCCURRED, DETACHED FROM THE TUBING AS THE CLINICIAN WAS PULLING IT OUT OF THE PT'S ARM. THE NEEDLE WAS STICKING HALF WAY INTO THE PT'S ARM AND HALF OUT. IT WAS STICKING OUT ENOUGH THAT THE CLINICIAN COULD PULL IT OUT OF THE PT'S ARM WITHOUT INCIDENT.