FDA Adverse Event
Malfunction
Summary report: N
INTERMATE
MDR report key: 3170222
·
Received June 14, 2013
Report
- Report Number
- 1416980-2013-15373
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Report Date
- May 22, 2013
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- FRN
- PMA / PMN Number
- K910425
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. 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 MULTI PACK 100 ML INTERMATE?S DEVICE HAD A SEPARATED DISTAL LUER. THE REPORTER STATED THAT THE TUBING BECAME DETACHED FROM THE PLASTIC AT THE BOTTOM OF THE LUER. THE EVENT WAS IDENTIFIED BY THE PATIENT PRIOR TO USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE. REPORT TWO OF THREE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271442 | INTERMATE | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - IRVINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |