PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED; HOWEVER, THREE (3) PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION. VISUAL EVALUATION OF THE PHOTOGRAPHS SHOWED A USED CATHETER THAT WAS SHEARED WITH THE COIL STRETCHED AND PULLED FROM THE INSIDE OF THE CATHETER. ALTHOUGH VISUAL EVALUATION DID SHOW A CATHETER WITH A SHEARED TIP AND STRETCHED COIL, IT DID NOT CONFIRM ANY MANUFACTURING DEFECT PRIOR TO THE USE OF THE CATHETER. B. BRAUN KITS ARE PACKAGED ACCORDING TO BLUEPRINT SPECIFICATIONS WHILE INSPECTING FOR ANY DEFECTS OR DEVIATIONS FROM DRAWING (E.G. EMBEDDED PARTICLES, DIRT, MISSING OR INCORRECTLY ASSEMBLED PARTS, ETC.). IN ADDITION, THERE ARE INCOMING, IN PROCESS AND FINAL FUNCTIONAL INSPECTIONS PERFORMED DURING THE MANUFACTURING OF COMPONENTS AND FINISHED GOOD ITEMS. PER THE MANUFACTURERS INVESTIGATION THIS DEFECT IS NOT LIKELY TO HAVE HAPPENED DURING THE MANUFACTURING PROCESS. IT IS BELIEVED TO HAPPEN DURING APPLICATION. USER SHOULD REFER TO THE INSTRUCTION FOR USE (IFU) WHICH STATES, "WARNINGS: DO NOT APPLY EXCESSIVE FORCE DURING NEEDLE ADVANCEMENT. DO NOT UTILIZE NEEDLE IF IT BENDS OR TIP BECOMES DAMAGED. NEEDLE WITH DAMAGED TIP INCREASES THE RISK OF INTRATHECAL OR INTRAVASCULAR PLACEMENT. IF RESISTANCE IS FELT DURING ADVANCEMENT OF THE NEEDLE, CAREFULLY CORRECT THE ORIENTATION OF THE NEEDLE BUT NEVER APPLY EXCESSIVE FORCE. FOLLOWING PUNCTURE AND VERIFICATION OF THE EPIDURAL SPACE, INTRODUCE CATHETER TIP THROUGH EPIDURAL NEEDLE USING THE THREAD ASSIST GUIDE. CAUTION: DO NOT WITHDRAW CATHETER THOUGH NEEDLE BECAUSE OF THE POSSIBLE DANGER OF SHEARING OR KINKING. INSERT CATHETER TO DESIRED DEPTH. PRECAUTION: ADVANCING THE CATHETER MORE THAN 5 CM PAST THE NEEDLE TIP MAY INCREASE THE LIKELIHOOD OF KINKING OR KNOTTING. IF THE CATHETER BECOMES DIFFICULT TO WITHDRAW, CONSULT STANDARD TEXTBOOKS FOR SPECIFIC TECHNIQUES." A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: CUSTOMER COMPLAINT ADVOCATE CALLED THE REPORTER WHILE ENTERING THE RECORD AND HE EXPLAINED THAT THE PLASTIC PORTION OF THE CATHETER TORE OFF WHILE TRYING TO ADMINISTER THE SPINAL TO A LABORING MOM WHO WANTED AN EPIDURAL. HE ADDED THAT THE DEVICE TORE WHILE HE WAS TRYING TO PULL THE CATHETER OUT, THAT THE WIRE WAS STILL IN THE PATIENT. AS THE WIRE WAS STRETCHED OUT AND LENGTHENED AND HAD TWISTED ON ITSELF, IT WAS HARD TO TELL IF A PIECE OF THE WIRE WAS EMBEDDED IN THE PATIENT OR JUST A PIECE OF THE PLASTIC. HE IS NOT SURE IF THE WIRE BROKE OFF OR NOT. HE FEELS LIKE MAYBE HE MADE AN ERROR BY TRYING TO READJUST THE NEEDLE WHILE PULLING THE CATHETER OUT AT THE SAME TIME. THAT MAYBE THE CATHETER NEEDLE BUT THE WIRE OR THE CATHETER - HE IS NOT SURE. AS THE PATIENT WANTED TO EPIDURAL, SHE NEEDED PAIN RELIEF - HE REMOVED EVERYTHING THAT HE COULD AND PLACED ANOTHER CATHETER. A PIECE WAS LEFT IN THE PATIENT. A CT SCAN REVEALED A 1-2CM FRAGMENT EMBEDDED IN THE PATIENT. PATIENT DID DELIVER THE BABY WITHOUT AN ADDITIONAL ISSUE AND IS BEING TREATED AT ANOTHER FACILITY AS THIS IS A SMALL ESTABLISHMENT SO THE PATIENT WAS TRANSFERRED TO ANOTHER LOCATION TO BE TREATED BY THE NEURO TEAM AS THEY MAY ELECT TO PERFORM BACK SURGERY. CUSTOMER COMPLAINT ADVOCATE CALLED THE CUSTOMER FACILITY CONTACT WHO REPORTED THAT THERE WAS ONLY ONE INCIDENT, AND THAT THE PATIENT WAS TRANSFERRED TO (B)(6). WHILE SHE REQUESTED THAT THE CATHETER BE REMOVED, THE HOSPITAL DID NOT MOVE FORWARD WITH ANY ADDITIONAL MEDICAL INTERVENTION, THEY DID NOT "THINK IT IS A GOOD IDEA AS THE PATIENT IS ASYMPTOMATIC". THE REPORTER STATED THAT HE HAS BEEN ATTENDING FOR 13 YRS AND HAS BEEN WORKING FOR THIS CUSTOMER FACILITY FOR 12 YEARS IN THIS HOSPITAL, THAT HE HAS PLACED 4,000 EPIDURALS, THAT HE LIKES DOING THIS PROCEDURE, BUT HE WOULD LIKE TO ADD THAT , PERHAPS IT WAS HIS FAULT, THAT HE MAY HAVE MISSED SOMETHING ALONG THE WAY IN HIS TRAINING, AS HE DOES NOT REMEMBER HEARING ABOUT ADJUSTING THE NEEDLE ONCE THE CATHETER IS PLACED...LAST TRAINING WAS 15 YEARS AGO - MAYBE SPRING ONE IS A LITTLE MORE PRONE FOR SHEARING. WITH THIS CATHETER IT IS NOT A GOOD IDEA TO PULL IT BACK THAT YOU HAVE TO PUT NEEDLE IN FIRST AND ONCE IT IS IN THE RIGHT SPACE PUT CATHETER IN, IF YOU FEEL RESISTANCE YOU DO NOT PULL THE CATHETER OUT AS THE END OF THE NEEDLE CAN BEND AND TEAR AND SHEAR THE SOFT MATERIAL OF THE CATHETER, AS THIS CATHETER IS SOFTER THAN THE NON-SPRING WOUND ONE OR THE CLASSIC ONES. CUSTOMER COMPLAINT ADVOCATE REPORTED THAT WE WILL CONSIDER HIS FEEDBACK - THAT SHE WILL SHARE THIS WITH MEDICAL AFFAIRS AND THE MARKETING MANAGERS FOR THIS PRODUCT LINE AND ADD IT TO THE RECORD AS WELL.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.