FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3173405
·
Received June 17, 2013
Report
- Report Number
- 1416980-2013-15592
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- May 7, 2013
- Report Date
- May 23, 2013
- Manufacturer
- BAXTER HEALTHCARE - AIBONITO
- Product Code
- FPB
- PMA / PMN Number
- K113227
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. SHOULD THE DEVICE OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE FILTER OF A 3 LEAD EXTENSION SET WITH 0.22 MICRON AIR ELIMINATING FILTER BECAME DISCOLORED (TURNING EITHER BROWN OR BLACK) DURING ADMINISTRATION OF FLAGYL. THE SET WAS CHANGED TWICE IN 24 HOURS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274313 | ACCESS | FILTER, INFUSION LINE | FPB | BAXTER HEALTHCARE - AIBONITO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | FLAGYL |