FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 4912859
·
Received July 14, 2015
Report
- Report Number
- 1416980-2015-28801
- Event Type
- Malfunction
- Date Received
- July 14, 2015
- Report Date
- June 29, 2015
- Manufacturer
- BAXTER HEALTHCARE - MALTA
- Product Code
- LJH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A UROMATIC ADMINISTRATION SET LEAKED FROM ITS SPIKE. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 455094 | ACCESS | SYSTEM, IRRIGATION, UROLOGICAL | LJH | BAXTER HEALTHCARE - MALTA | 14K03V521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |