BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN
Report
- Report Number
- 2210968-2025-00640
- Event Type
- Malfunction
- Date Received
- January 16, 2025
- Date of Event
- December 24, 2024
- Report Date
- June 20, 2025
- Manufacturer
- ETHICON INC.
- Product Code
- GBX
- UDI-DI
- 10705031003552
- PMA / PMN Number
- CL I EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. D4: UDI: THE MANUFACTURING DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. WHAT IS THE LOT NUMBER OF THE BLAKE DRAIN (2227) INVOLVED? LOT NUMBER: UNK : J2309094, J2307655. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR LOC/BQ). THE EVENT DESCRIBES A RESERVOIR. WAS THERE AN ISSUE WITH THE DRAIN? DID IT REQUIRE REPLACEMENT OF THE DRAIN? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: D4 LOT: UNKNOWN LOT: POSSIBLE LOTS: J2309094, J2307655 D4. EXPIRATION DATE, H4: LOT: J230909 MFG. DATE 08-DEC-23, EXP. DATE - 08-DEC-28, LOT: J2307655 MFG. DATE 05-OCT-23 EXP. DATE - 05-OCT-28 ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. AS 2 LOTS FOR THE DRAIN WERE PROVIDED. ARE THESE POSSIBLE LOTS OR WAS MORE THAN ONE DRAIN EXPERIENCED LEAKAGE? THE LOTS ARE THE POSSIBLE LOTS. THE RESERVOIR HAS BEEN RECEIVED FOR ANALYSIS. HOWEVER, THE DRAIN AS MARKED AS SHIPPED BUT HAS NOT BEEN RECEIVED. PLEASE REVIEW THE SHIPPING INFORMATION AND INDICATE IF IT MAY HAVE BEEN INADVERTENTLY MARKED AS SHIPPED TO CG LABS OR POSSIBLY LOST. THE DEVICE WAS SENT. H3 EVALUATION: NO PRODUCT RETURNED FOR ANALYSIS. DOCUMENTS REVIEW : DURING INVESTIGATION OF COMPLAINT, BATCH REVIEW OF IN-PROCESS AND FINAL PACKAGING INSPECTIONS, AS WELL AS THE MANUFACTURING PROCESS IS PERFORMED, THESE PRODUCTS ARE REPORTED TO BE MANUFACTURED, INSPECTED, AND PACKAGED IN CONFORMANCE WITH CUSTOMER'S SPECIFICATIONS AND HAVE BEEN FOUND TO BE ACCEPTABLE WITHIN ALL PARAMETERS. NO DISCREPANCY AS PER THE REPORTED DEFECT IS OBSERVED. RETENTION SAMPLE REVIEW : NO NEGATIVE OBSERVATION WAS FOUND. REVIEW OF DEFECTIVE SAMPLE'S IMAGE / VIDEO : NOT APPLICABLE, AS THERE WAS NO COMPLAINT SAMPLE IMAGE / VIDEO RECEIVED FOR EVALUATION. AS PER STANDARD PRACTICE, 100% FUNCTIONAL TEST AND 100% VISUAL INSPECTION WAS CARRIED OUT, BEFORE AND AFTER PACKING OF FINISHED GOODS, PRIOR TO THE PRODUCT RELEASE. THERE WAS NO SCOPE TO MISS SUCH DEFECT, AT MANUFACTURING / RELEASE STAGE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AS 2 LOTS FOR THE DRAIN WERE PROVIDED. ARE THESE POSSIBLE LOTS OR WAS MORE THAN ONE DRAIN EXPERIENCED LEAKAGE? THE DRAIN AS MARKED AS SHIPPED BUT HAS NOT BEEN RECEIVED. PLEASE REVIEW THE SHIPPING INFORMATION AND INDICATE IF IT MAY HAVE BEEN INADVERTENTLY MARKED AS SHIPPED OR POSSIBLY LOST. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. WHAT IS THE LOT NUMBER OF THE BLAKE DRAIN (2227) INVOLVED? =>J2309094, J2307655 WHAT IS THE LOT NUMBER OF THE JVAC RESERVOIR (2178) INVOLVED? =>JU0943 PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. =>THE DEVICE HAS BEEN RECEIVED AT SUKAGAWA AND WILL BE SHIPPED. PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR LOC/BQ) =>HIROMI TOKUYAMA THE EVENT DESCRIBES A RESERVOIR. WAS THERE AN ISSUE WITH THE DRAIN?=>YES DID IT REQUIRE REPLACEMENT OF THE DRAIN?=>UNK THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: UNK-POSSIBLE LOTS: D4. LOT: J2309094. H4 MANUFACTURE DATE: (B)(6) 2023. D4. EXPIRATION DATE: (B)(6) 2028. D4. PRIMARY UDI NUMBER: (B)(4). D4. LOT: J2307655. H4 MANUFACTURE DATE: (B)(6) 2023. D4. EXPIRATION DATE: (B)(6) 2028. D4. PRIMARY UDI NUMBER: (B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4) ADDITIONAL INFORMATION: D9. H3 EVALUATION: COMPLAINT SAMPLE REVIEW: ONE COMPLAINT SAMPLE OF DRAIN WITHOUT ANY TROCAR WAS RECEIVED FOR EVALUATION, PRODUCT WAS CHECKED VISUALLY AND FOUND THAT THE TUBING AREA HAD A DEEP CRACK. DOCUMENTS REVIEW: DURING INVESTIGATION OF COMPLAINT, BATCH REVIEW OF IN-PROCESS AND FINAL PACKAGING INSPECTIONS, AS WELL AS THE MANUFACTURING PROCESS IS PERFORMED, THESE PRODUCTS ARE REPORTED TO BE MANUFACTURED, INSPECTED, AND PACKAGED IN CONFORMANCE WITH CUSTOMER'S SPECIFICATIONS AND HAVE BEEN FOUND TO BE ACCEPTABLE WITHIN ALL PARAMETERS. NO DISCREPANCY AS PER THE REPORTED DEFECT IS OBSERVED. RETENTION SAMPLE REVIEW : NO NEGATIVE OBSERVATION WAS FOUND. REVIEW OF DEFECTIVE SAMPLE'S IMAGE / VIDEO : NOT APPLICABLE, AS THERE WAS NO COMPLAINT SAMPLE IMAGE / VIDEO RECEIVED FOR EVALUATION. AS PER STANDARD PRACTICE, 100% FUNCTIONAL TEST AND 100% VISUAL INSPECTION WAS CARRIED OUT, BEFORE AND AFTER PACKING OF FINISHED GOODS, PRIOR TO THE PRODUCT RELEASE. THERE WAS NO SCOPE TO MISS SUCH DEFECT, AT MANUFACTURING / RELEASE STAGE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2024 AND A DRAIN WAS USED. THE RESERVOIR HAD BEEN SWELLED QUICKLY DUE TO AN AIR LEAK DURING THE SURGERY. A NEW ONE OPEN WAS OPENED AND USED WITHOUT PROBLEMS. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1792221 | BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN | CATHETER, IRRIGATION | GBX | ETHICON INC. | 10705031003552 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |