UROPASS AS 12/14FR X 54 CM 5/BX

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED. THE CUSTOMER RETURNED THREE 61254BX (UROPASS AS 12/14FR X 54CM) IN THE SAME TYVEK PACKAGE. TWO OF THE DEVICES WERE HEAVILY COVERED IN BLOOD/RESIDUE AND THE THIRD ONE WAS NOT. THIS DEVICE WAS RETURNED WITH A BROKEN TIP. AS MENTIONED, IT WAS HEAVILY COVERED IN BLOOD/RESIDUE FROM BEING INSERTED INTO THE PATIENT. PICTURES WERE TAKEN AND WILL BE SENT TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION. THIS DEVICE IS MANUFACTURED BY THE THIRD PARTY VENDOR TELEFLEX. THE OEM REPORTED THAT THE (61254BX ) 500038-38, BATCH: 09C1500205 COMPLAINT WAS SHIPPED ON 18-MAR-2015 WITH A LOT QUANTITY OF 181 FOR A TOTAL OF FIVE PACKS (B)(4) UNITS). THE PRODUCT WAS MANUFACTURED USING THREE DILATOR LOTS: T5637-12, BATCHES: 08M1400342, 08A1500541, AND 08C1500303. THESE DEVICES WERE MANUFACTURED OVER FOUR YEARS PRIOR TO THIS COMPLAINT. THE SHELF LIFE FOR THIS PRODUCT WAS REDUCED FROM 60 MONTHS TO 30 MONTHS ON MANUFACTURING DOCUMENTS ON 15-MAR-2019. THIS PRODUCT WOULD BE CONSIDERED EXPIRED ACCORDING TO THE UPDATED PRINT. A DHR REVIEW WAS CONDUCTED AND ALL THREE DILATOR LOTS PASSED INSPECTION AND NO ABNORMALITIES WERE NOTED. THE DILATOR COMPLAINT IS A KNOWN PROBLEM THAT HAS BEEN INVESTIGATED PREVIOUSLY. OLYMPUS DILATOR BREAK INVESTIGATION WAS CONDUCTED FEBRUARY 2015- REFERENCE DOCUMENT (TELEFLEX NOTIFICATIONS: (B)(4). BASED ON SIMILAR REPORTS, THE ROOT CAUSE IS ENVIRONMENTALLY RELATED EXPOSURE OF THE DEVICE IN THE HEALTH CARE FACILITIES WHICH RESULTED IN DEGRADATION AND EMBRITTLEMENT OF THE DILATOR POLYMER, TELEFLEX BELIEVES THERE IS NO MANUFACTURING, MATERIAL, OR PROCESS RELATED CAUSE FOR THIS FAILURE MODE THAT WOULD BE CONSIDERED WITHIN TELEFLEX¿S CONTROL. SINCE TELEFLEX IS NOT RESPONSIBLE FOR DESIGN VALIDATION, ACCELERATED AGING, AND STORAGE/ENVIRONMENTAL EVALUATION OF THE DEVICE POST STERILIZATION. NO FURTHER ACTION WILL BE TAKEN AT THIS TIME REGARDING THIS ISSUE.

Additional Manufacturer Narrative

USER FACILITY REPORTED ABOUT THE THREE DEVICES AND THIS IS FOR THE SECOND DEVICE THAT WAS NOTED TO BE BROKEN OUT OF THE PACKAGE. THE DEVICE WAS NOT RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. THE INSTRUCTION MANUAL PROVIDES WARNING AND CAUTION STATEMENTS IN AN EFFORT TO PREVENT BREAKAGE; " DO NOT INSERT THIS DEVICE WITHOUT COMPREHENSIVE KNOWLEDGE OF THE INDICATIONS, TECHNIQUES, AND RISKS ASSOCIATED WITH THE PROCEDURE. DO NOT INSERT THIS DEVICE IF IT HAS BEEN KINKED OR DAMAGED PRIOR TO USE. REPLACE WITH UNDAMAGED PRODUCT. AVOID CONTACT WITH SHARP OBJECTS AS THE DEVICE CAN BE EASILY NICKED, THEREBY INCREASING THE POTENTIAL FOR BREAKAGE.¿

Description of Event or Problem

THE CENTER WAS INFORMED THAT DURING A THERAPEUTIC CYSTOSCOPY WITH RETROGRADES, LASER LITHOTRIPSY, AND STONE REMOVAL PROCEDURE, THE SHEATH WAS OPENED BY A REGISTERED NURSE (RN) AND PASSED TO SURGICAL TECHNICIAN AND THEN TO THE STERILE FIELD. AFTER THE SHEATH WAS INSERTED INTO THE PATIENT IT WAS NOTED TO BE BROKEN. A SECOND SHEATH WAS THEN OPENED AND PASSED TO THE STERILE FIELD. UPON OPENING THIS PACKAGE, IT WAS NOTED TO BE BROKEN DIRECTLY OUT OF THE PACKAGE. THEREFORE, A THIRD SHEATH WAS OPENED AND PASSED TO THE STERILE FIELD. IT WAS FOUND TO BE INTACT, NOT BROKEN AND THEREFORE INSERTED INTO THE PATIENT. ONCE INSIDE THE PATIENT, IT WAS OBSERVED THROUGH CAMERA THAT THE SHEATH HAD BROKEN INTO MULTIPLE PIECES. THE SHEATH WAS IMMEDIATELY REMOVED FROM THE PATIENT. THE SURGEON EXTRACTED ALL VISUALIZED FRAGMENTS ABLE TO BE EXTRACTED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF THE ACCESS SHEATH. THERE WAS NO PATIENT INJURY REPORTED. IN ADDITION, THE USER FACILITY REPORTED THAT MATERIALS MANAGEMENT WAS NOTIFIED AND REMOVED REMAINING ITEMS IMMEDIATELY FOLLOWING THE CASE. THIS IS 2 OF 3 REPORTS.