NAVARRE OPTI DRAIN
Report
- Report Number
- 3006260740-2025-09265
- Event Type
- Malfunction
- Date Received
- December 4, 2025
- Date of Event
- November 11, 2025
- Report Date
- January 13, 2026
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- GBX
- UDI-DI
- 00801741037030
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THREE ELECTRONIC PHOTOS WERE PROVIDED AND REVIEWED. THE FIRST PHOTO SHOWS THE PARTIAL VIEW OF CATHETER WITHIN THE PLASTIC SEALED PACKAGING WITH ATTACHED LABEL AND ANOTHER SEALED DEVICE ALSO NOTED WERE ON THE FLOOR. LOT INFORMATION WAS VERIFIED WITH TW. ANOTHER DEVICE WAS NOTED TO BE BLUR. THREAD BREAK CANNOT BE VERIFIED DUE TO PARTIAL VISIBLE OF TIP AND HOLES OF THE CATHETER. THE SECOND PHOTO SHOWS THE PARTIAL VIEW OF CATHETER WITHIN THE PLASTIC SEALED PACKAGING WITH ATTACHED LABEL. THREAD WAS NOT NOTED WITHIN THE CATHETER PIG TAIL AND GOT SEPARATED. BREAK WAS SEPARATION WERE NOTED. THE THIRD PHOTO SHOWS THE PARTIAL VIEW OF SECONDARY PACKAGING BOX WITH ATTACHED LABEL. LOT AND PRODUCT INFORMATION WERE MATCH WITH TW. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED THREAD DIGRESSION ISSUE FOR ONE DEVICE. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED THREAD DIGRESSION ISSUE FOR ANOTHER TWO DEVICES AS PROVIDED PHOTO ARE NOT SUFFICIENT AND BREAK AND SEPARATION DOES NOT CLEAR ENOUGH TO CONFIRM THE ISSUE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. G3, H6 (METHOD, RESULT, CONCLUSION) SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.
H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. POST THE PROCEDURE, THE SURE-LOKTM THREAD WAS ALLEGEDLY DIGRESSIONED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. POST THE PROCEDURE, THE SURE-LOKTM THREAD WAS ALLEGEDLY DIGRESSIONED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2834636 | NAVARRE OPTI DRAIN | CHRONIC CATHETERS | GBX | C.R. BARD, INC. (BASD) -3006260740 | GFKN0714 | 00801741037030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |