HYDRAGLIDE SILICONE CATHETERS STRAIGHT

Additional Manufacturer Narrative

A FOLLOW UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF HE INVESTIGATION INTO THIS EVENT.

Description of Event or Problem

CUSTOMER STATES THAT A "HAIR" WAS FOUND INSIDE OF A JUST OPENED CHEST TUBE. IT WAS NOT USED ON PATIENT.

Additional Manufacturer Narrative

ANALYSIS - THE 24FR SILICONE-XL CATHETER WAS RETURNED AND WAS IN THE ORIGINAL PACKAGING. THE PACKAGING HAD BEEN FULLY OPENED AND HAD BEEN STAPLED SHUT. UPON INSPECTION A HUMAN HAIR WAS FOUND TO BE LAYING LENGTHWISE DOWN THE OUTSIDE OF THE SILICONE CATHETER. THE HAIR WAS APPROXIMATELY 4¿ INCHES IN LENGTH. A HAIR OF THIS LENGTH WOULD CERTAINLY BEEN VISIBLE DURING THE 200% INSPECTION CONDUCTED DURING THE PROCESS OF MANUFACTURING FOR FOREIGN MATERIAL. UNFORTUNATELY BECAUSE THE SILICONE CATHETER PACKAGING HAD BEEN OPENED THERE IS NO WAY TO CONFIRM THAT THE HAIR WAS INTRODUCED PRIOR TO THE FINAL PACKAGING SEALING OPERATION OR IF IT WAS INTRODUCED IN THE FIELD WHEN THE SILICONE CATHETER WAS OPENED. A REVIEW OF THE MANUFACTURING PROCEDURE CATHETER INSPECTION AND PACKAGING INDICATES THAT EVERY CATHETER IS 100% INSPECTED PRIOR TO PACKAGING TO ENSURE THE PRODUCT WHEN PLACED IN THE POUCH IS CLEAN. ONCE THE PART IS PLACED INTO THE POUCH THE PRODUCT IS AGAIN INSPECTED TO ENSURE THERE ARE NO CONTAMINATES WITHIN THE PACKAGE AND HAIR OF ANY KIND IS UNACCEPTABLE. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THAT THIS LOT OF 24 FR SILICONE CATHETERS PASSED ALL QUALITY REQUIREMENTS PRIOR TO BEING RELEASED AND THERE HAVE BEEN NO NON-CONFORMANCES RELATED TO HAIR BEING FOUND IN THE PACKAGED PRODUCT. A REVIEW OF THE COMPLAINT HISTORY RECORDS GOING BACK THREE FULL YEARS INDICATES THAT THERE HAVE BEEN NO OTHER REPORTED INCIDENTS OF HAIR BEING FOUND ON ANY OF THE SILICONE CATHETER PRODUCTS. A REVIEW OF THE INCOMING MATERIALS FROM THE SUPPLIER SHOW THAT THIS LOT OF 24 FR SILICONE CATHETERS PASSED ALL INCOMING INSPECTION REQUIREMENTS. SUMMARY/CONCLUSION - BASED ON THE INVESTIGATION ATRIUM MEDICAL CORPORATION CANNOT CONCLUDE THAT THE HAIR WAS PRESENT IN THE PACKAGE PRIOR TO THE INSTITUTION OPENING THE SEALED POUCH OF THE 24FR SILICONE CATHETER OR IF THE HAIR FELL INTO THE PACKAGE UPON OPENING THE SEALED POUCH AT THE INSTITUTION. ALL ATRIUM MEDICAL CORPORATION PRODUCTS ARE MANUFACTURED AND PACKAGED WITHIN A CLEAN ROOM ENVIRONMENT WHERE ALL EFFORTS ARE MADE TO ENSURE THAT THE PRODUCTS ARE CLEAN AND FREE OF LOOSE FIBERS OR HAIRS. THE PROCEDURE FOR GOWNING PRIOR TO ENTERING THE CLEAN ROOM REQUIRES ALL STAFF MEMBERS TO BE SUITED IN A ONE PIECE FULL BODY GOWN WITH TWO SEPARATE BOUFFANT CAPS THAT COVER ALL HAIR AND BEARD COVERS IF REQUIRED AND FULL FOOT COVERAGE BOOTIES. ALL MANUFACTURING PERSONNEL ARE TRAINED ON PROPER GOWNING TECHNIQUES.

Description of Event or Problem

N/A.