FDA Adverse Event
Malfunction
Summary report: N
30327 12CC 100 UNIT HEP SYR {CAN} (5CC)
MDR report key: 1033754
·
Received April 23, 2008
Report
- Report Number
- 3002859087-2008-00011
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- January 1, 2008
- Report Date
- April 15, 2008
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- NZW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE 4/15/2008. 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 ON 04/15/2008 THAT A CUSTOMER HAD A PROBLEM WITH THE HEPARIN PREFILLED SYRINGES. THE CUSTOMER REPORTS THAT THE PT RECEIVED A HEPARIN INJECTION AND HAD AN ANAPHYLACTIC REACTION AND HAS RECEIVED MEDICAL ATTENTION.
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |