FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3161591
·
Received June 11, 2013
Report
- Report Number
- 1416980-2013-14915
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Report Date
- March 21, 2013
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FPA
- PMA / PMN Number
- K961225
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IV TUBING OF A BASIC SOLUTION SET WAS CRIMPED. THE SET WAS "NOT WORKING WELL IN AN UNKNOWN NEURO-PACK." IT IS UNKNOWN DURING WHICH PROCESS STEP THIS MALFUNCTION HAD OCCURRED. THEREFORE IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261821 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE | R12D18208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN NEURO-PACK |