DOUBLE LUMEN BRONCHIAL TUBE SET LEFT
Report
- Report Number
- 8040412-2023-00387
- Event Type
- Injury
- Date Received
- November 9, 2023
- Date of Event
- October 27, 2023
- Report Date
- October 27, 2023
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTS
- PMA / PMN Number
- K951091
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN# (B)(4). THE SAMPLE WAS RETURNED TO THE MANUFACTURING SITE. THE SITE REPORTED: "ONE ACTUAL SAMPLE AND 3 PHOTOGRAPHS WERE RECEIVED AND REVIEWED. THE INNER LUMEN WAS INSPECTED USING MAGNIFICATION CAMERA UPON CROSS SECTION AND OBSERVED WITH PROTRUDED FRAGMENT IN INNER LUMEN AT ANGULAR CONNECTOR BLUE (BRONCHIAL). ANGULAR CONNECTOR WHITE (TRACHEAL) WAS ALSO INSPECTED USING MAGNIFICATION CAMERA UPON CROSS SECTION AND OBSERVED WITH PROTRUDED FRAGMENTED IN INNER LUMEN. BASED ON INVESTIGATION CONDUCTED, THE COMPLAINT ON THIS COMPLAINT MODE WAS CONFIRMED. THE PROTRUDED FRAGMENT IN INNER LAYER WAS OBSERVED AT ANGULAR CONNECTOR BLUE (BRONCHIAL) AND ANGULAR CONNECTOR WHITE (TRACHEAL). THEREFORE, FURTHER INVESTIGATION AND CORRECTIVE ACTION WILL BE DOCUMENTED IN AN INVESTIGATION OPENED WITHIN TELEFLEX." TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
(B)(4). IN SECTION D PROVIDED THE FULL UDI #. UDI RELATED DATA QUALITY UPDATES ONLY.
(B)(4). N/A. OTHER REMARKS: N/A. CORRECTED DATA: N/A.
IT WAS REPORTED THAT "IN THE BRONCHIAL EXTENSION PIECE OF THE DLB-TUBE PLASTIC FRAGMENTS WERE FOUND DURING USE. THE DLB-TUBE WAS CORRECTLY INSERTED WITHOUT USING ANY AIDS LIKE A BOUGIE OR SIMILAR. THE FRAGMENTS WERE NOTED IN THE FIRST PASSAGE DURING BSK IN THE BRONCHIAL EXTENSION TUBE OF THE DLB-TUBE. DLB-TUBE WAS REMOVED AND A NEW ONE WAS INSERTED, DURING BSK NO FRAGMENTS WERE FOUND IN THE PATIENTS LUNGE. CUSTOMER ASSUMES THAT THIS FRAGMENTS COMING FROM A BULGE BETWEEN THE EXTENSION PIECE AND THE CONNECTOR WHICH HAS BEEN NOTED MORE OFTEN FOR THESE DLB-TUBES". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
IT WAS REPORTED THAT "IN THE BRONCHIAL EXTENSION PIECE OF THE DLB-TUBE PLASTIC FRAGMENTS WERE FOUND DURING USE. THE DLB-TUBE WAS CORRECTLY INSERTED WITHOUT USING ANY AIDS LIKE A BOUGIE OR SIMILAR. THE FRAGMENTS WERE NOTED IN THE FIRST PASSAGE DURING BSK IN THE BRONCHIAL EXTENSION TUBE OF THE DLB-TUBE. DLB-TUBE WAS REMOVED AND A NEW ONE WAS INSERTED, DURING BSK NO FRAGMENTS WERE FOUND IN THE PATIENTS LUNGE. CUSTOMER ASSUMES THAT THIS FRAGMENTS COMING FROM A BULGE BETWEEN THE EXTENSION PIECE AND THE CONNECTOR WHICH HAS BEEN NOTED MORE OFTEN FOR THESE DLB-TUBES". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
IT WAS REPORTED THAT "IN THE BRONCHIAL EXTENSION PIECE OF THE DLB-TUBE PLASTIC FRAGMENTS WERE FOUND DURING USE. THE DLB-TUBE WAS CORRECTLY INSERTED WITHOUT USING ANY AIDS LIKE A BOUGIE OR SIMILAR. THE FRAGMENTS WERE NOTED IN THE FIRST PASSAGE DURING BSK IN THE BRONCHIAL EXTENSION TUBE OF THE DLB-TUBE. DLB-TUBE WAS REMOVED AND A NEW ONE WAS INSERTED, DURING BSK NO FRAGMENTS WERE FOUND IN THE PATIENTS LUNGE. CUSTOMER ASSUMES THAT THIS FRAGMENTS COMING FROM A BULGE BETWEEN THE EXTENSION PIECE AND THE CONNECTOR WHICH HAS BEEN NOTED MORE OFTEN FOR THESE DLB-TUBES". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93080 | DOUBLE LUMEN BRONCHIAL TUBE SET LEFT | TUBE, BRONCHIAL (W/WO CONNECT | BTS | TELEFLEX MEDICAL | IPN047053 | 40E23D3587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | N/A.| N/A.| N/A. |