FDA Adverse Event
Malfunction
Summary report: N
INTERMATE
MDR report key: 6012730
·
Received October 7, 2016
Report
- Report Number
- 1416980-2016-16075
- Event Type
- Malfunction
- Date Received
- October 7, 2016
- Report Date
- October 7, 2016
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- FRN
- PMA / PMN Number
- K910425
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BLADDER OF A SMALL VOLUME INTERMATE RUPTURED. THIS OCCURRED AFTER FILLING WITH 80ML OF SODIUM CHLORIDE SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 661685 | INTERMATE | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - IRVINE | NA | 15M018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |