FDA Adverse Event
Malfunction
Summary report: N
30327 12CC 100 UNIT HEP SYR {CAN} (5CC)
MDR report key: 1131623
·
Received August 21, 2008
Report
- Report Number
- 3002859087-2008-00048
- Event Type
- Malfunction
- Date Received
- August 21, 2008
- Report Date
- August 14, 2008
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- NZW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD A PROBLEM WITH A HEPARIN PREFILLED SYRINGE. THE CUSTOMER REPORTS THAT A PT WHO HAD BEEN USING THE HEPARIN FLUSH SYRINGE DIED. PT HAD A HISTORY OF MDS (MYELODISPLASTIC SYNDROME) AND WAS BEING TREATED FOR A PSEUDOMONAS INFECTION. A PICC LINE WAS PLACED FOLLOWING THE THIRD HOSPITALIZATION FOR THE INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 30327 12CC 100 UNIT HEP SYR {CAN} (5CC) | HEPARIN PREFILLED SYRINGE | NZW | TYCO HEALTHCARE/KENDALL | 8881590125 | 7072054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |