N
Patient 1
OCCUPATION: VALUE ANALYSIS FACILITATOR. 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 9652889
- MDR report key
- 9652889
- Report number
- 1820334-2020-00256
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-23
- Date received
- 2020-01-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- UNK 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 | 2020-01-31 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT UPON OPENING A THAL-QUICK CHEST TUBE TRAY, THE INCLUDED LIDOCAINE BOTTLE WAS FOUND EMPTY WITH AN OPEN SEAL. ADDITIONALLY, THE SCALPEL INCLUDED IN THE SET WAS OPEN AND HAD DRIED BLOOD ON IT. THE PROCEDURE WAS MOMENTARILY STOPPED AND THE KIT WAS SEQUESTERED. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.