N
Patient 1
(B)(6). 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 9823620
- MDR report key
- 9823620
- Report number
- 1820334-2020-00596
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-12-26
- Date received
- 2020-03-12
- 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 | 2020-03-12 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT A LOCK PERICARDIOCENTESIS CATHETER SET WAS SELECTED FOR A PERICARDIOCENTESIS PROCEDURE. UPON OPENING THE PACKAGE, THE USER FOUND THAT THE WIRE GUIDE INSIDE WAS KINKED. THE USER THEN OPENED ANOTHER PACKAGE TO COMPLETE THE PROCEDURE. THE DEVICE DID NOT MAKE PATIENT CONTACT. UPON PRELIMINARY ANALYSIS OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE WIRE COATING HAD FLAKED OFF IN SEVERAL SPOTS ON THE DISTAL CURVE WHERE KINKING WAS NOTED.