FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 4242134
·
Received November 10, 2014
Report
- Report Number
- 1416980-2014-39821
- Event Type
- Malfunction
- Date Received
- November 10, 2014
- Date of Event
- October 3, 2014
- Report Date
- October 14, 2014
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FPA
- PMA / PMN Number
- K112893
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT NO: CMPLNT-(B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER AND IS CURRENTLY AWAITING EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SOFT TUBING OF A CLEARLINK SOLUTION SET WAS LEAKING. THE REPORTER WAS UNABLE TO FURTHER SPECIFY THE LOCATION OF THE LEAK. THIS OCCURRED DURING INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 722005 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |