FDA Adverse Event
Malfunction
Summary report: N
ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
MDR report key: 7008991
·
Received November 8, 2017
Report
- Report Number
- 1820334-2017-03845
- Event Type
- Malfunction
- Date Received
- November 8, 2017
- Date of Event
- October 20, 2014
- Report Date
- November 7, 2017
- Manufacturer
- COOK INC
- Product Code
- EYI
- UDI-DI
- 00827002126381
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION: COMMON DEVICE NAME IS "GBO." DUE TO A TECHNICAL ISSUE, THIS INFORMATION COULD NOT BE SAVED IN THE PROPER FIELD, SO IT IS BEING RECORDED HERE. D4- RPN- ULT12.0-38-25-P-5S-CLDM-TONG-050399. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL CAP008, 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 PRIOR TO PATIENT CONTACT, LEAKAGE OCCURRED FROM THE CATHETER'S HUB AREA, A NEW PRODUCT WAS USED. THERE WAS NO OF INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 791431 | ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER | EYI | COOK INC | 00827002126381 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |