FDA Adverse Event
Malfunction
Summary report: N
INS SAF SYR 1CC 29X1 / 2IN
MDR report key: 2123610
·
Received June 10, 2011
Report
- Report Number
- 1915484-2011-00013
- Event Type
- Malfunction
- Date Received
- June 10, 2011
- Date of Event
- December 2, 2010
- Report Date
- May 16, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2011. 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH AN INSULIN SYRINGE. THE CUSTOMER REPORTS THAT THE SAFETY SHIELD SLIPPED DURING ACTIVATION AND THE NURSE RECEIVED A DIRTY NEEDLE STICK. IN RESPONSE, THE NURSE WAS TREATED AT AN OUTPATIENT FACILITY AND UNDERWENT BLOOD BORNE PATHOGEN TESTING. NO ADD'L INJURY HAS BEEN REPORTED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INS SAF SYR 1CC 29X1 / 2IN | INSULIN SYRINGE | FMF | COVIDIEN | 8881511110 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |