FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3831709
·
Received May 26, 2014
Report
- Report Number
- 1416980-2014-16952
- Event Type
- Malfunction
- Date Received
- May 26, 2014
- Report Date
- April 29, 2014
- Manufacturer
- BAXTER HEALTHCARE - AIBONITO
- Product Code
- FPA
- PMA / PMN Number
- K132734
- 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 AND THE LOT NUMBER WAS NOT AVAILABLE; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
A CUSTOMER REPORTED HAVING DIFFICULTY INITIATING FLUID MOVEMENT WHILE USING THE ONE-LINK Y-TYPE MICROBORE CATHETER EXTENSION SET. ACCORDING TO THE REPORT, THE CUSTOMER WAS UNABLE TO ACCESS THE SITE, FLUSH, ADMINISTER MEDICATIONS OR DRAW BLOOD. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309978 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - AIBONITO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |