FDA Adverse Event
Malfunction
Summary report: N
INS SAF SYR 1CC 29X1/2IN
MDR report key: 2961024
·
Received January 15, 2013
Report
- Report Number
- 1915484-2013-00001
- Event Type
- Malfunction
- Date Received
- January 15, 2013
- Report Date
- January 4, 2013
- Manufacturer
- COVIDIEN
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2013. 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH AN INSULIN SYRINGE. THE CUSTOMER REPORTS THE SAFETY SHIELD CAME OFF THE TOP OF THE NEEDLE. THE CUSTOMER REPORTS NO ONE WAS INJURED. THERE WERE TWO LOTS ON THE CART; THE CUSTOMER IS UNSURE WHICH LOT IT CAME FROM. THE NEEDLE WAS DISPOSED OF AT THE TIME OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 22195 | INS SAF SYR 1CC 29X1/2IN | INSULIN SYRINGE | FMF | COVIDIEN | 8881511110 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |