SAFETY CLR MURPHY CUF ET
Report
- Report Number
- 8040412-2024-00179
- Event Type
- Malfunction
- Date Received
- July 31, 2024
- Date of Event
- June 12, 2024
- Report Date
- July 5, 2024
- Manufacturer
- TELEFLEX MEDICAL SDN. BHD.
- Product Code
- BTR
- UDI-DI
- 14026704341426
- PMA / PMN Number
- K961837
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
(B)(4).
IT IS REPORTED THAT: "SUBSTITUTE PRODUCT IS TOO LONG SO GLIDESCOPE STYLET DOES NOT REACH THE DISTAL END OF ETT, PRODUCT IS TOO STIFF OF PLASTIC CAUSING TRAMA TO AIRWAYS, PRODUCT'S ETT ADAPTOR EASILY DISCONNECTS, PRODUCT DIFFICULT TO REMOVE FROM PACKAGING WITHOUT CONTAMINATING. THERE WAS NO REPORTED PATIENT HARM." ASSOCIATED COMPLAINTS (B)(4).
IT IS REPORTED THAT: "SUBSTITUTE PRODUCT IS TOO LONG SO GLIDESCOPE STYLET DOES NOT REACH THE DISTAL END OF ETT, PRODUCT IS TOO STIFF OF PLASTIC CAUSING TRAMA TO AIRWAYS, PRODUCT'S ETT ADAPTOR EASILY DISCONNECTS, PRODUCT DIFFICULT TO REMOVE FROM PACKAGING WITHOUT CONTAMINATING. THERE WAS NO REPORTED PATIENT HARM." ASSOCIATED COMPLAINTS 8040412-2024-00180, AND 8040412-2024-00176.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 913635 | SAFETY CLR MURPHY CUF ET | TUBE, TRACHEAL (W/WO CONNECTOR | BTR | TELEFLEX MEDICAL SDN. BHD. | 40E23H3765 | 14026704341426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NOT REPORTED| NOT REPORTED |