BEBACK CROSSING CATHETER

Description of Event or Problem

THE FOLLOWING INFORMATION WAS PROVIDED BY THE DISTRIBUTOR TO BENTLEY: "PER THE REP: YESTERDAY, WHILE PREPARING FOR A CASE, I OPENED THE PACKAGING OF A BEBACK CATHETER AND OBSERVED THAT THE NEEDLE WAS ALREADY EXTENDED FROM THE CATHETER. ADDITIONALLY, THE PLASTIC BARRIER OF THE INNER PACKAGING APPEARED COMPROMISED, WITH VISIBLE HOLES. PLEASE NOTE THE FOLLOWING: THE DEVICE WAS NOT FULLY OPENED. IT WAS NOT PROVIDED TO HOSPITAL STAFF. NO HARM OCCURRED TO THE PATIENT." BASED ON THIS INFORMATION OUR CURRENT UNDERSTANDING IS THAT THE STERILE BARRIER OF THE DEVICE WAS COMPRIMISED, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY ACCORDING TO THE RISK ASSESSMENT OF THIS CASE.

Additional Manufacturer Narrative

EXPLANATION FOR PERFORMING NO DEVICE EVALUATION (FIELD H3): DESPITE MULTIPLE REQUESTS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND THEREFORE, COULD NOT BE EXAMINED. RESULTS OF THE INVESTIGATION: THE REVIEW OF THE PRODUCTION DOCUMENTS WAS PERFORMED BY UPSTREAM AND SHOWED NO ABNORMALITIES. THE DEVICE LEFT THE MANUFACTURING SITE ACCORDING TO ITS SPECIFICATIONS. UNFORTUNATELY, THE PRODUCT WAS NOT RETURNED, AND NO IMAGE DATA WAS PROVIDED FOR THIS INVESTIGATION. THEREFORE, THIS INVESTIGATION WAS CONDUCTED SOLELY BASED ON THE SUBMITTED INFORMATION, THE PRODUCTION DOCUMENTS AS WELL AS ON OUR MARKET EXPERIENCE AND THE INVESTIGATION RESULTS OF PREVIOUS COMPLAINT CASES. THE ISSUE WAS IDENTIFIED BY THE CUSTOMER PRIOR TO USE, AND THE PRODUCT WAS NOT APPLIED TO A PATIENT. DESPITE MULTIPLE REQUESTS FOR RETURN, THE COMPLAINED PRODUCT WAS NOT RETURNED TO THE MANUFACTURER AND WAS THEREFORE UNAVAILABLE FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED PRODUCTION LOT SHOWED THAT ALL MANUFACTURING WAS IN ACCORDANCE TO THE SPECIFICATIONS. CONSIDERING THIS AND BASED ON THE RECEIVED INFORMATION ONE POSSIBLE EXPLANATION FOR THE PROTRUDED NEEDLE MIGHT BE LINKED TO THE TRANSPORT OF THE DEVICE. MECHANICAL INFLUENCES SUCH AS COMPRESSION, VIBRATION, OR STACKING LOADS DURING DISTRIBUTION MAY CONTRIBUTE TO INCREASED STRESS WITHIN THE PACKAGE. THIS WAS CONSIDERED AND SUCCESSFULLY SIMULATED DURING THE TRANSPORT VALIDATION (IVEV 600F) OF THE BEBACK. THE BEBACK DEVICES ARE DISTRIBUTED WITH A LOCKED NEEDLE, WHICH USUALLY PREVENTS THE NEEDLE TO PROTRUDE DURING THE TRANSPORT AND AVOID POTENTIAL DAMAGES ON THE STERILE BARRIER SYSTEM OF THE DEVICE. SINCE THE CLAIMED DEVICE WAS UNFORTUNATELY NOT RETURNED TO THE MANUFACTURER THE PROTRUDED NEEDLE AND THE SUBSEQUENT DAMAGED STERILE BARRIER COULD NOT BE CONFIRMED. FURTHERMORE, SINCE THE PACKAGING WAS NOT AVAILABLE FOR INVESTIGATION FACTORS LIKE UNUSUAL EXTREME TRANSPORT CONDITIONS COULD NOT BE INVESTIGATED. NEVERTHELESS, IT CAN NOT BE RULED OUT THAT THERE WAS UNUSUAL ROUGH HANDLING DURING THE TRANSPORTATION OF THE DEVICE WHICH COULD HAVE LED TO A PROTRUDED NEEDLE AND A RESULTING DAMAGE ON THE STERILE BARRIER SYSTEM OF THE DEVICE. THIS ASSUMPTION CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED TO BENTLEY FOR INVESTIGATION NOR CAN BE RULED OUT. DISCUSSION AND CONCLUSION: THE REVIEW OF THE PRODUCTION DOCUMENTS WAS PERFORMED BY UPSTREAM AND SHOWED NO ABNORMALITIES. THE DEVICE LEFT THE MANUFACTURING SITE ACCORDING TO ITS SPECIFICATIONS. THE CLAIMED DEVICE WAS UNFORTUNATELY NOT RETURNED TO BENTLEY FOR INVESTIGATION. THEREFORE, THE PROTRUDED NEEDLE AND THE RESULTING DAMAGE TO THE STERILE BARRIER COULD NOT BE CONFIRMED. IN GENERAL, THE DEVICE UNDERWENT EXCESSIVE TESTING DURING THE PRODUCT DEVELOPMENT AND DURING THIS TESTING NO PROTRUDED NEEDLE WAS DETECTED AFTER A TRANSPORT SIMULATION OF THE DEVICES. SINCE THE CLAIMED DEVICE WAS NOT RETURNED POSSIBLE ROOT CAUSES, E.G. UNUSUAL ROUGH TRANSPORTING CONDITIONS COULD NOT FURTHER BE ASSESSED. THE BEBACK DEVICES ARE DISTRIBUTED WITH A LOCKED NEEDLE, WHICH PREVENTS THE NEEDLE TO PROTRUDE DURING THE TRANSPORT AND AVOID POTENTIAL DAMAGES ON THE STERILE BARRIER SYSTEM OF THE DEVICE. BASED ON THE OBTAINED RESULTS THE ROOT CAUSE FOR THE UNSATISFYING PERFORMANCE OF THE DEVICE OR A DEVICE MALFUNCTION CANNOT BE CONFIRMED AND IS DEEMED AS HIGHLY IMPROBABLE BASED ON THE AVAILABLE INFORMATION.

Description of Event or Problem

THE FOLLOWING INFORMATION WAS PROVIDED BY THE DISTRIBUTOR TO BENTLEY: "PER THE REP: YESTERDAY, WHILE PREPARING FOR A CASE, I OPENED THE PACKAGING OF A BEBACK CATHETER AND OBSERVED THAT THE NEEDLE WAS ALREADY EXTENDED FROM THE CATHETER. ADDITIONALLY, THE PLASTIC BARRIER OF THE INNER PACKAGING APPEARED COMPROMISED, WITH VISIBLE HOLES. PLEASE NOTE THE FOLLOWING: THE DEVICE WAS NOT FULLY OPENED. IT WAS NOT PROVIDED TO HOSPITAL STAFF. NO HARM OCCURRED TO THE PATIENT." BASED ON THIS INFORMATION OUR CURRENT UNDERSTANDING IS THAT THE STERILE BARRIER OF THE DEVICE WAS COMPROMISED, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY ACCORDING TO THE RISK ASSESSMENT OF THIS CASE.