VERASEAL DUAL APPLICATOR CE
Report
- Report Number
- 2210968-2024-09909
- Event Type
- Malfunction
- Date Received
- September 18, 2024
- Date of Event
- January 1, 2024
- Report Date
- March 7, 2025
- Manufacturer
- ETHICON INC.
- Product Code
- MZM
- PMA / PMN Number
- BK180287
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT #:(B)(4). ADDITIONAL INFORMATION: D4 ¿ THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE THE POSSIBLE BATCH NUMBERS: 3336831 AND 3296666 THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 1. IS THE USER A NEW USER TO VERASEAL? IF NOT, HOW MANY TIMES HAVE THEY USED VISTASEAL PRIOR TO THIS EVENT? 2. HOW MANY TIMES HAVE THEY APPLIED THE LAPAROSCOPIC TIP? 3. WAS A SALES REPRESENTATIVE PRESENT DURING THE CASE WHEN THE ISSUE WAS EXPERIENCED? 4. WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? 5. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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). CORRECTED B5 NARRATIVE: IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE FIBRIN SEALANT PREPARATION DEVICE WAS USED. ACCORDING TO THE NORMAL DE-ICING OPERATION, THE NURSING STAFF PUT THE FIBRIN SEALANT PREPARATION DEVICE INTO ROOM TEMPERATURE WITH NORMAL SALINE FOR 5 MINUTES TO DE-ICE IT. WHEN IT WAS TAKEN OUT AND ASSEMBLED AND HANDED OVER TO THE DOCTOR FOR USAGE, IT WAS FOUND THAT THE SHORT CONNECTOR COULD NOT BE UNSCREWED SMOOTHLY AND THE CONNECTOR WAS BROKEN, SO THE PRODUCT DID NOT GO SMOOTHLY. USED ON PATIENTS. THEY CHANGED TO A NEW ONE WHEN THE EVENT OCCURRED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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). CORRECTED INFORMATION: D 4. PRIMARY UDI NUMBER. ADDITIONAL INFORMATION: H 6. TYPE OF INVESTIGATION. D4: FULL UDI CURRENTLY UNAVAILABLE SINCE THE EXACT LOT OF THE SUSPECTED DEVICE CANNOT BE DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE POSSIBLE FINISHED DEVICE LOTS, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION: D4, H4 ¿ THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE THE POSSIBLE BATCH NUMBERS: BATCH 3296666 MFG DATE: 11/28/2022, EXP DATE: 11/11/2027. BATCH 3336831 MFG DATE: 3/02/2023, EXP DATE: 3/09/2028 . THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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). H6. INVESTIGATION FINDINGS: C22 ¿ PHOTO INVESTIGATION. H 6. COMPONENT CODE: NO CONCLUSION. PHOTO INVESTIGATION SUMMARY-THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS THE CONNECTORS OF VERASEAL DUAL APPLICATOR CE. THE IMAGE IS NOT CLEAR TO DETERMINE THE FAILURE MODE OR THE REPORTED CONDITION. BASED ON THE PHOTO REVIEW, THE EVENT DESCRIBE IS NOT CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE DEVICE WAS NOT RETURNED OUR EVALUATION IS LIMITED. WE VALUE THE OPPORTUNITY TO FULLY ANALYZE THE DEVICE UPON ITS RETURN. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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). H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE VRAAS1 DEVICE WAS RETURNED WITH THE ADAPTER BROKEN AND THE LUER LOCKS DAMAGED. THE PRE-FILLED SYRINGE EMPTY AND TWO (2) EXTRA AIRLESS SPRAY TIPS. IN ADDITION, THE SECONDARY BOX AND THE PACKAGING OPENED. DUE TO THE CONDITION OF THE RETUNED DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. AS PART OF ETHICON¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT REPORTED WAS CONFIRMED AND IT IS RELATED TO IMPROPER USE OF THE DEVICE. ONE POSSIBLE CAUSE FOR THE DAMAGE FOUND ON THE ADAPTER MAY BE EXCESSIVE EXTERNAL LOAD PLACED ON THE DEVICE. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. ADDITIONAL INFORMATION: GRIFOLS LETTER: THE INVOLVED DEVICE WAS RETURNED TO ETHICON FOR EVALUATION. THE INVESTIGATION CONDUCTED BY ETHICON INDICATED THE FOLLOWING: VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE DEVICE WAS RETURNED WITH THE ADAPTER BROKEN AND THE LUER LOCKS DAMAGED. THE PRE-FILLED SYRINGE EMPTY AND TWO EXTRA AIRLESS SPRAY TIPS. IN ADDITION, THE SECONDARY BOX AND THE PACKAGING OPENED. DUE TO THE CONDITION OF THE RETUNED DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. AS PART OF ETHICON'S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ACCORDING TO THE RESULTS PROVIDED BY ETHICON, THE EVENT REPORTED IS RELATED TO THE IMPROPER USE OF THE DEVICE. ONE POSSIBLE CAUSE FOR THE DAMAGE FOUND ON THE ADAPTER MAY BE EXCESSIVE EXTERNAL LOAD PLACED ON THE DEVICE. BASED ON THE INVESTIGATION PERFORMED, IT CAN BE CONCLUDED THAT THIS NOTIFICATION DOES NOT SEEM TO BE RELATED TO THE QUALITY OF THE PRODUCT NEITHER TO THE RELATED COMPONENTS. WE WOULD LIKE TO REMARK THE IMPORTANCE OF FOLLOWING THE LEAFLET INSTRUCTIONS AND HIGHLIGHT THE FOLLOWING INDICATION: DO NOT USE ANY EXTERNAL ELEMENT OR TOOL TO DISSEMBLE THE TIPS, UNSCREW THE LUER LOCKS MANUALLY. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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). H6 COMPONENT CODE: G07002 - PENDING EVALUATION OF RETURNED DEVICE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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 THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. ACCORDING TO THE NORMAL DE-ICING OPERATION, THE NURSING STAFF PUT THE FIBRIN SEALANT PREPARATION DEVICE INTO ROOM TEMPERATURE WITH NORMAL SALINE FOR 5 MINUTES TO DE-ICE IT. WHEN IT WAS TAKEN OUT AND ASSEMBLED AND HANDED OVER TO THE DOCTOR FOR USAGE, IT WAS FOUND THAT THE SHORT CONNECTOR COULD NOT BE UNSCREWED SMOOTHLY AND THE CONNECTOR WAS BROKEN, SO THE PRODUCT DID NOT GO SMOOTHLY. USED ON PATIENTS. THEY CHANGED TO A NEW ONE WHEN THE EVENT OCCURRED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1490236 | VERASEAL DUAL APPLICATOR CE | FIBRIN SEALANT PREPARATION DEVICE | MZM | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |