FDA Adverse Event
Malfunction
Summary report: N
INS SAF SYR 1CC 29X1 / 2IN
MDR report key: 2123609
·
Received June 10, 2011
Report
- Report Number
- 1915484-2011-00014
- Event Type
- Malfunction
- Date Received
- June 10, 2011
- Date of Event
- February 11, 2011
- 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 WHILE THE NURSE WAS ACTIVATING THE SAFETY SHIELD, THE PT KICKED THEIR LEG AND BUMPED THE NURSE'S ARM, RESULTING IN 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 |