FDA Adverse Event
Death
Summary report: N
UNKNOWN PREFILL
MDR report key: 2070281
·
Received April 20, 2011
Report
- Report Number
- 3002859087-2011-00015
- Event Type
- Death
- Date Received
- April 20, 2011
- Date of Event
- March 1, 2008
- Report Date
- April 18, 2011
- Manufacturer
- COVIDIEN
- Product Code
- NZW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 04/19/2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
ON (B)(6) 2011, COVIDIEN WAS INFORMED OF A CUSTOMER WHO HAD AN ISSUE WITH A HEPARIN PREFILLED SYRINGE. THE ATTORNEY ALLEGES THAT IN LATE (B)(6) 2008, THE PT WAS ADMINISTERED HEPARIN AT THE HOSPITAL. SHORTLY THEREAFTER, THE PT BEGAN TO EXPERIENCE SYMPTOMS CONSISTENT WITH THE ADVERSE REACTIONS ASSOCIATED WITH CONTAMINATED HEPARIN. UPON INFO AND BELIEF, THE ALLEGED THEREON, ON AT LEAST ONE OCCASION, THE HEPARIN ADMINISTERED TO THE PT WAS CONTAMINATED HEPARIN. THE PT PASSED ON (B)(6) 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PREFILL | HEPARIN PREFILL | NZW | COVIDIEN | UNKNOWN PREFILL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |