FDA Adverse Event
Malfunction
Summary report: N
MAGELLAN INSULIN 1ML 29GX1/2"
MDR report key: 2140553
·
Received June 13, 2011
Report
- Report Number
- 1915484-2011-00015
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Report Date
- June 6, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
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 NURSES HAVE COMPLAINED THAT THE NEEDLE IS TOO SOFT AND TOO FLEXIBLE MAKING IT DIFFICULT TO MANIPULATE WITH THE SMALL BOTTLE AND REPORTEDLY SOMETIMES THE NEEDLE BREAKS. THE CUSTOMER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFO REGARDING HOW OR IN WHAT MANNER THE NEEDLE BROKE, THE QUANTITY OF DEFECTIVE NEEDLES, THE DATE OF EVENTS OR IF THERE WAS ANY PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAGELLAN INSULIN 1ML 29GX1/2" | INSULIN SYRINGE | FMF | COVIDIEN | 8881892910 | 030027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |