FDA Adverse Event
Malfunction
Summary report: N
CONCORD ENDOSCOPIC CHOLANGIOGRAPHY SET
MDR report key: 8167902
·
Received December 16, 2018
Report
- Report Number
- 1820334-2018-03824
- Event Type
- Malfunction
- Date Received
- December 16, 2018
- Date of Event
- June 17, 2015
- Report Date
- December 16, 2018
- Manufacturer
- COOK INC
- Product Code
- GBZ
- UDI-DI
- 00827002028470
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE CONCORD ENDOSCOPIC CHOLANGIOGRAPHY SET WAS REMOVED FROM THE PACKAGE AND DURING PRIMING OF THE CATHETER, THE FLUID STARTED SPRAYING OUT OF THE SIDE BEFORE IT GOT TO THE DISTAL END OF THE CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES TO THE PATIENT OR USER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1007221 | CONCORD ENDOSCOPIC CHOLANGIOGRAPHY SET | GBZ CATHETER, CHOLANGIOGRAPHY | GBZ | COOK INC | NA | 5800528 | 00827002028470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |