FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3133437
·
Received May 29, 2013
Report
- Report Number
- 1416980-2013-13582
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Report Date
- May 3, 2013
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FPA
- PMA / PMN Number
- K112893
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THE TUBING OF A SOLUTION SET, NON-DEHP, HAD SNAPPED OFF DURING AN INFUSION OF BLOOD. THE NURSE WAS TRYING TO SHIFT THE BLUE CLAMP AND THE TUBING HAD SNAPPED. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO ADVERSE EVENT HAD BEEN REPORTED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236014 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE | R11C30164 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |