N
Patient 1
PATIENT CODE: (B)(4). PMA/510(K) #: EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
MAUDE MDR 9667033
- MDR report key
- 9667033
- Report number
- 1820334-2020-00279
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-06-18
- Date received
- 2020-02-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. JENNIFER CANADA
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-04 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED A FEMALE PATIENT REQUIRED AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER USED FOR NEPHROSTOMY DRAINAGE. THE DEVICE WAS PLACED ON (B)(6) 2019. THE OPERATOR REPORTED THAT ON (B)(6) 2019 THE CATHETER BECAME BLOCKED AND REQUIRED REMOVAL. ON REMOVAL, THE OPERATOR NOTED THE TIP WAS BLOCKED AND THEY WERE UNABLE TO PASS A GUIDE WIRE THROUGH CATHETER. ADDITIONALLY, THE CATHETER DID NOT WANT TO UNLOCK EASILY FOR REMOVAL. ANOTHER SIMILAR DEVICE WAS PLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.