FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3981417
·
Received August 5, 2014
Report
- Report Number
- 1416980-2014-25376
- Event Type
- Malfunction
- Date Received
- August 5, 2014
- Date of Event
- April 9, 2014
- Report Date
- July 11, 2014
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN UNKNOWN NITRO SET WITH DUO VENT SPIKE LEAKED AT ¿ONE OF THE WHITE STOPPERS¿ THAT HOLDS THE CLAMP. THIS OCCURRED DURING PRIMING, AND THE SET WAS BRAND NEW. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458494 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |