FDA Adverse Event
Malfunction
Summary report: N
UNK PREFILL
MDR report key: 1629850
·
Received March 9, 2010
Report
- Report Number
- 3002859087-2010-00095
- Event Type
- Malfunction
- Date Received
- March 9, 2010
- Report Date
- March 5, 2010
- Manufacturer
- COVIDIEN
- Product Code
- NZW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
ON 03.05.10, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. THE ATTORNEY ALLEGES THAT IN OR ABOUT THE PERIOD FOR (B) (6) 2007 THROUGH (B) (6) 2008, THE HEPARIN LOCK FLUSH PRODUCT THAT CONTAINED ALLEGED CONTAMINANTS WAS ULTIMATELY ADMINISTERED TO THE PT AND THE PT WAS CAUSED TO AND DID SUFFER PHYSICAL INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK PREFILL | HEPARIN PREFILL | NZW | COVIDIEN | UNK PREFILL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |