FDA Adverse Event
Malfunction
Summary report: N
INTERMATE
MDR report key: 4063626
·
Received September 5, 2014
Report
- Report Number
- 1416980-2014-29739
- Event Type
- Malfunction
- Date Received
- September 5, 2014
- Report Date
- August 14, 2014
- 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
(B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). THIS LOT WAS MANUFACTURED FROM NOVEMBER 4, 2013 ¿ NOVEMBER 5, 2013. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SMALL VOLUME INTERMATE HAD A MISSING CAP ("TIP"). THIS MALFUNCTION WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS MEDICAL DEVICE REPORT 2 OF 3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 544652 | INTERMATE | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - IRVINE | 13M001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |