FDA Adverse Event
Malfunction
Summary report: N
ANGEL WING 23G BCS W/LUER ADPTR
MDR report key: 3793208
·
Received January 15, 2014
Report
- Report Number
- 1282497-2014-00005
- Event Type
- Malfunction
- Date Received
- January 15, 2014
- Date of Event
- January 9, 2014
- Report Date
- March 9, 2014
- Manufacturer
- COVIDIEN
- Product Code
- GJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39193 | ANGEL WING 23G BCS W/LUER ADPTR | BLOOD COLLECTION SET | GJE | COVIDIEN | 8881225307 | 132770093X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |