VERASEAL DUAL APPLICATOR CE
Report
- Report Number
- 2210968-2025-13271
- Event Type
- Malfunction
- Date Received
- November 26, 2025
- Date of Event
- October 31, 2025
- Report Date
- January 20, 2026
- Manufacturer
- ETHICON INC.
- Product Code
- MZM
- PMA / PMN Number
- BK180287
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: D4, H4 ¿ THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING POSSIBLE LOT NUMBERS WERE REPORTED: 3462586 AND 3528730 BATCH 3462586 MFG DATE: 12/16/2023, EXP DATE: 12/16/2028 BATCH 3528730 MFG DATE: 05/07/2024, EXP DATE: 05/08/2029 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE POSSIBLE FINISHED DEVICE LOTS, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. 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: D9. DEVICE AVAILABLE FOR EVALUATION? ADDITIONAL INFORMATION: D 9. DATE DEVICE RETURNED TO MANUFACTURER, D 9. IS DEVICE RETURNED TO MANUFACTURER?, H 6. COMPONENT CODE, H 6. TYPE OF INVESTIGATION, H 6. INVESTIGATION FINDINGS, H 6. INVESTIGATION CONCLUSIONS. H6 COMPONENT CODE: G07002 - PENDING EVALUATION OF RETURNED DEVICE. THE DEVICE UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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: H 3. DEVICE EVALUATED BY MANUFACTURER? ADDITIONAL INFORMATION: H 6. COMPONENT CODE, H 6. TYPE OF INVESTIGATION, H 6. INVESTIGATION FINDINGS, H 6. INVESTIGATION CONCLUSIONS. H3 INVESTIGATION SUMMARY ACCORDING TO INFORMATION RECEIVED, WHEN THE OT SCRUB NURSE WAS DISCONNECTING THE DUAL APPLICATOR FOR VERASEAL (PRODUCT CODE VRAAS1), THE SECTION WITH THE GREY LUER LOCKS BROKE OFF AND COULD NOT BE REATTACHED. A NEW VERASEAL WAS USED AND FUNCTIONED AS EXPECTED, WITH NO PATIENT INVOLVEMENT REPORTED. THE PRODUCT WAS RETURNED TO ETH 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 SPRAY AND DRIP TIP DAMAGED INSIDE A PLASTIC BAG. IN ADDITION, TWO (2) EXTRA AIRLESS SPRAY TIPS AND THE SECONDARY BOX WAS RETURNED ALONG WITH THE INSTRUMENT. ADDITIONALLY, PHOTOS WERE PROVIDED AND THEY SHOWED THE CONDITION OF THE REPORTED EVENT. AS PART OF ETH QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE REPORTED COMPLAINT WAS CONFIRMED. 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 IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. ADDITIONAL INFORMATION: LNSTITUTO GRIFOLS, S.A. (IG) UPON RECEIPT OF THE REPORTED INCIDENT, ADDITIONAL INFORMATION WAS REQUESTED TO SUPPORT THE INVESTIGATION, INCLUDING THE PREVIOUS EXPERIENCE OF THE USER WITH THE DEVICE, LEAKAGE OBSERVED IN THE CONNECTION AREA, AS WELL AS THE AVAILABILITY OF PICTURES. THE FOLLOWING INFORMATION WAS PROVIDED: THE USER IS NOT NEW. SHE HAS PREPARED VERASEAL FOR CASES MANY TIMES. PICTURES WERE AVAILABLE. ADDITIONALLY, THE AFFECTED SAMPLE WAS RECEIVED AT ETHICON FACILITIES FOR EVALUATION. IN ACCORDANCE WITH IG'S STANDARD PROCEDURES, AN INVESTIGATION WAS INITIATED FOCUSING ON: A. EVALUATION OF THE PROVIDED PICTURE: FIGURE 1 ILLUSTRATES THE DAMAGE TO THE AFFECTED UNIT: THE CONNECTION POINTS IN THE DUAL APPLICATOR, WHERE THE LUER LOCKS ARE POSITIONED AND THE TIP ATTACHED, ARE BROKEN. B. INVESTIGATION OF THE DUAL APPLICATOR TIP: CONSIDERING THE NATURE OF THE REPORTED INCIDENT, IT WAS REQUESTED TO ETHICON TO CARRY OUT AN INVESTIGATION OF THE BATCH OF TIPS INVOLVED, AS ETHICON IS THE SUPPLIER OF VERASEAL DUAL APPLICATOR. THE INVESTIGATION WAS FOCUSED ON REVIEWING THE RESULTS OF BATCH RECORDS FOR THE BATCHES OF TIPS USED. IT WAS CONCLUDED THAT ALL THE COMPONENTS PARTS UTILIZED FOR THE INVOLVED BATCHES MET THE ESTABLISHED SPECIFICATIONS WITH NO INCIDENTS RELATED. C. EVALUATION OF THE RETURNED SAMPLE AT ETHICON FACILITIES. THE VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE DEVICE WAS RETURNED WITH THE ADAPTER BROKEN AND SPRAY AND DRIP TIP DAMAGED. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED ACCORDING TO APPROVED SPECIFICATIONS. ACCORDING TO ETHICON'S INVESTIGATION, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE REPORTED COMPLAINT WAS CONFIRMED. D. RESULTS OF QUALITY CONTROL PERFORMED AT IG FACILITIES: LNSTITUTO GRIFOLS, S.A. REVIEWED THE RESULTS OF THE QUALITY CONTROLS PERFORMED TO THE INCOMING MATERIALS (DUAL APPLICATOR) INVOLVED IN THE NOTIFICATION. A REVIEW OF THE RESULTS RELATED TO THE LUER LOCK FUNCTIONALITY PERFORMED TO INCOMING TIPS KITTED WITH THE INVOLVED BATCH, A04J124641, WAS PERFORMED. THE RESULTS WERE FOUND CORRECT WITHIN SPECIFICATIONS AND NO DEVIATIONS WERE DETECTED. BASED ON THE INFORMATION DETAILED ABOVE, IT CAN BE CONCLUDED THAT ALL THE PROCEDURES CARRIED OUT AT IG FACILITIES WERE CONDUCTED IN ACCORDANCE WITH ESTABLISHED PROTOCOLS, WITH NO ANOMALIES DETECTED. ALTHOUGH NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS NOTIFICATION, THE EVALUATION OF THE PROVIDED PICTURE AND THE INVESTIGATION PERFORMED SUPPORT THE CONCLUSION THAT THE REPORTED INCIDENT IS NOT RELATED TO THE QUALITY OF THE PRODUCT OR ITS COMPONENTS. ONE POSSIBLE CAUSE FOR THE DAMAGE FOUND ON THE ADAPTER MAY BE EXCESSIVE EXTERNAL LOAD PLACED ON THE DEVICE. 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 AND 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). D4 UDI NUMBER: UDI/GTIN UNAVAILABLE AS THIS DEVICE IS FROM A KIT. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. IS THE USER A NEW USER TO VERASEAL? IF NOT, HOW MANY TIMES HAVE THEY USED VERASEAL PRIOR TO THIS EVENT? ¿ NOT A NEW USER. SHE HAS PREPARED VERASEAL FOR CASES MANY TIMES. 2. WAS A SALES REPRESENTATIVE PRESENT DURING THE CASE WHEN THE ISSUE WAS EXPERIENCED? ¿ NO. 3. WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? ¿ NO LEAKAGE OBSERVED. 4. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? ¿ NO. 5. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? ¿YES. 6. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, 7. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO PATIENT INVOLVEMENT, THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: -WAS PROCEDURE SUCCESSFULLY COMPLETED? --> UNKNOWN, -WERE FRAGMENTS GENERATED? --> UNKNOWN, -IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, -WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, -IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, ADDITIONAL INFORMATION: D4 - THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE POSSIBLE BATCH NUMBERS ARE REPORTED AS FOLLOWS: 3528730 AND 3462586 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 (B)(6) 2025 AND HEMOSTATIC AGENT DUAL APPLICATOR DEVICE WAS USED. WHEN THE OT SCRUB NURSE WAS DISCONNECTING THE DUAL APPLICATOR FOR THE PRODUCT, SO AS TO ATTACH THE LAPAROSCOPIC APPLICATOR, THE SECTION WITH THE GREY LUER LOCKS BROKE OFF AND COULD NOT BE REATTACHED. SHE OPENED A NEW ONE FROM THE OT AND THAT ITEM WAS FINE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2812993 | VERASEAL DUAL APPLICATOR CE | FIBRIN SEALANT PREPARATION DEVICE | MZM | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |