FDA Adverse Event
Malfunction
Summary report: N
CYSTOSCOPY IRRIGATION SET
MDR report key: 6084388
·
Received November 7, 2016
Report
- Report Number
- 1416980-2016-17013
- Event Type
- Malfunction
- Date Received
- November 7, 2016
- Report Date
- November 7, 2016
- Manufacturer
- BAXTER HEALTHCARE - CARTAGO
- Product Code
- LJH
- PMA / PMN Number
- K960787
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CYSTO/BLADDER IRRIGATION SET DISCONNECTED FROM A NON-BAXTER STOPCOCK, LEADING TO A LEAK. THIS OCCURRED DURING INFUSION OF STERILE WATER, STERILE NORMAL SALINE, AND STERILE GLYCINE DURING AN UNSPECIFIED CYSTOSCOPIC PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 734674 | CYSTOSCOPY IRRIGATION SET | SYSTEM, IRRIGATION, UROLOGICAL | LJH | BAXTER HEALTHCARE - CARTAGO | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | STERILE GLYCINE| STERILE NORMAL SALINE| STERILE WATER| WOLF STOPCOCK |