SPECULUM TUBING, 10MM, CORRUGATED, WITH CANNULA CONNECTOR

Additional Manufacturer Narrative

(B)(4). DATE SENT: 2/29/2024. D4 BATCH # UNK. B3: ONLY EVENT YEAR KNOWN: 2024. LOT NUMBER WAS RECEIVED AND DHR IS PENDING REVIEW. WHEN THE REVIEW IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT WITH A SUMMARY OF THE EVALUATION. 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ACCOUNT RECEIVED A REPLACEMENT ITEM WHERE ON THE BOX IT SHOWS EXP 8/2048 BUT ON THE ITEM IT SHOWS EXP 3/2024. NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

(B)(4) DATE SENT: 3/27/2024.

Additional Manufacturer Narrative

(B)(4). DATE SENT: 4/11/2024 INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICES. VISUAL ANALYSIS OF THE 25 RETURNED SAMPLES DETERMINED THAT THE 2395J FILTERS WERE RECEIVED IN THEIR INDIVIDUAL STERILE PACKAGING WITH NO APPARENT DAMAGE. DUE TO THE CARTON BOX WAS NOT RETURNED, WE WERE UNABLE TO FURTHER INVESTIGATE THE REPORTED EVENT. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE FILTER PERFORMED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH 211197, AND NO NON-CONFORMANCES WERE IDENTIFIED.