PARKER
Report
- Report Number
- 3000219639-2025-00048
- Event Type
- Malfunction
- Date Received
- May 16, 2025
- Report Date
- August 15, 2025
- Manufacturer
- PARKER MEDICAL
- Product Code
- CBI
- UDI-DI
- 00607411959493
- PMA / PMN Number
- K092886
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 16 MAY 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
CORRECTION: D4; E1. ADDITIONAL INFORMATIO- INVESTIGATION CONCLUSION: H6; H11. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE REPORTER PROVIDED PHOTOGRAPHIC/VIDEOGRAPHIC EVIDENCE OF THE REPORTED MALFUNCTION; EVALUATION OF THIS EVIDENCE CONFIRMED THE COMPLAINT AS REPORTED. THE ROOT CAUSE COULD NOT BE DETERMINED. DHR: THE VENDOR WAS NOTIFIED OF THE INCIDENT. ALL INFORMATION REASONABLY KNOWN AS OF 15 AUG 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
IT WAS REPORTED, DURING LAPAROSCOPIC RESECTION OF A MALIGNANT LUNG TUMOR, A TRACHEAL TUBE WAS INSERTED INTO THE PATIENT IN THE SUPINE POSITION. AFTER THE PATIENT'S POSITION WAS CHANGED TO THE LEFT SIDE LYING POSITION THE PATIENT WAS CHECKED WITH A BRONCHIAL FIBERGLASS AND A LEAK FROM THE BRONCHIAL CUFF WAS DISCOVERED. THE PATIENT WAS RETURNED TO THE SUPINE POSITION AND REINTUBATED. THE CUFF WAS [SUBSEQUENTLY] INSPECTED AND A CUT WAS VERIFIED; THERE WAS NO REPORTED INJURY TO THE PATIENT.
IT WAS REPORTED, DURING LAPAROSCOPIC RESECTION OF A MALIGNANT LUNG TUMOR, A TRACHEAL TUBE WAS INSERTED INTO THE PATIENT IN THE SUPINE POSITION. AFTER THE PATIENT'S POSITION WAS CHANGED TO THE LEFT SIDE LYING POSITION THE PATIENT WAS CHECKED WITH A BRONCHIAL FIBERGLASS AND A LEAK FROM THE BRONCHIAL CUFF WAS DISCOVERED. THE PATIENT WAS RETURNED TO THE SUPINE POSITION AND REINTUBATED. THE CUFF WAS [SUBSEQUENTLY] INSPECTED AND A CUT WAS VERIFIED; THERE WAS NO REPORTED INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98948 | PARKER | ENDO-BRONCH, STANDARD TIP, DOUBLE LUMEN TUBE, LEFT, 37 FR | CBI | PARKER MEDICAL | I-PSTDL-37 | 2410DL2952D | 00607411959493 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |