SAFETY CLR MURPHY CUF ET
Report
- Report Number
- 8040412-2023-00321
- Event Type
- Malfunction
- Date Received
- August 21, 2023
- Date of Event
- August 1, 2023
- Report Date
- August 4, 2023
- Manufacturer
- TELEFLEX MEDICAL SDN. BHD.
- Product Code
- BTR
- UDI-DI
- 14026704341433
- PMA / PMN Number
- K961837
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4), COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
QN#(B)(4) .
IT WAS REPORTED THAT "THE PATIENT WAS INTUBATED, THE DOCTOR INFLATED THE BALLOON AND REALIZED THAT THE BALLOON WAS DEFLATING AND DECIDED TO REMOVE THE TUBE AND PLACE ANOTHER ONE." PER THE CUSTOMER, IT IS UNKNOWN IF THERE WAS ANY PATIENT HARM, DESATURATION OR INJURY OR THE PATIENT'S CURRENT STATUS. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
IT WAS REPORTED THAT "THE PATIENT WAS INTUBATED, THE DOCTOR INFLATED THE BALLOON AND REALIZED THAT THE BALLOON WAS DEFLATING AND DECIDED TO REMOVE THE TUBE AND PLACE ANOTHER ONE." PER THE CUSTOMER, IT IS UNKNOWN IF THERE WAS ANY PATIENT HARM, DESATURATION OR INJURY OR THE PATIENT'S CURRENT STATUS. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1906418 | SAFETY CLR MURPHY CUF ET | TUBE, TRACHEAL (W/WO CONNECTOR | BTR | TELEFLEX MEDICAL SDN. BHD. | KME22C2437 | 14026704341433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |