FDA Adverse Event
Injury
Summary report: N
ACCESS
MDR report key: 3133202
·
Received May 29, 2013
Report
- Report Number
- 1416980-2013-13502
- Event Type
- Injury
- Date Received
- May 29, 2013
- Report Date
- May 2, 2013
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FPA
- PMA / PMN Number
- K981792
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE EXACT DATE OF THIS EVENT IS UNKNOWN; HOWEVER, THE EVENT OCCURRED APPROXIMATELY AROUND (B)(6) 2013. AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CLEARLINK PACLITAXEL SET LEAKED FROM THE TUBING DURING PRIMING. THE DEVICE WAS BEING USED WITH AN UNKNOWN CHEMOTHERAPY SOLUTION, A BAG, AND A PUMP. REPORTEDLY, THE NURSE NOTICED A KINK IN THE TUBING, WHICH WAS LATER IDENTIFIED AS A CUT, AND WHEN SHE MOVED THE TUBING, CHEMOTHERAPY SOLUTION LEAKED ONTO HER HANDS. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235535 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |