HENRY SCHEIN

Description of Event or Problem

THE CUSTOMER REPORTS THAT WHILE THE PATIENT WAS AT THE CLINIC FOR ANTIOXIDANTE INFUSION ON SUNDAY AT 10:12 THE RN UTILIZED THE HENRY SCHEIN REF 570-2587 LOT 50539/0350, EXPIRATION DATE 2030-06-21 22G SAFETY IV CATHETER TO INSERT CLIENT'S IV TO HIS L-AC. DURING IV INSERTION, THIS RN OBSERVED A FLASH OF BLOOD IN THE TUBING OF THE IV CATHETER. TOURNIQUET WAS REMOVED AND THEN RN ADVANCED THE CATHETER SUCCESSFULLY INTO THE PATIENT'S VEIN. THE PATIENT HAS NO MEDICAL HISTORY AND IS HEALTHY. AS THE RN WAS RETRACTING THE NEEDLE, SHE OBSERVED A DROP OF BLOOD AT THE INSERTION SITE. THE NURSE ATTACHED THE PRIMED EXTENSION SET TO THE CATHETER, ATTEMPTED TO FLUSH, AND SUDDENLY THE PLASTIC CATHETER DISCONNECTED FROM THE TIP OF THE BLUE TRANSLUCENT HUB. UPON ASSESSMENT THERE WAS MILD REDNESS AND NO VISIBLE PLASTIC PRESENT AT INSERTION SITE, BUT STILL PALPABLE IN THE AREA. THE PATIENT WAS INSTRUCTED TO GO TO THE NEARBY HOSPITAL WHERE THEY REMOVED IT SURGICALLY AND STITCHED IT BUT NUMBER OF STITCHES NOT KNOWN. THE PATIENT REPORTED NO COMPLICATIONS AND DOING WELL AT THIS TIME.

Additional Manufacturer Narrative

THE CUSTOMER REPORTS THAT WHILE THE PATIENT WAS AT THE CLINIC FOR ANTIOXIDANTE INFUSION ON SUNDAY AT 10:12 THE RN UTILIZED THE HENRY SCHEIN REF 570-2587 LOT 50539/0350, EXPIRATION DATE 2030-06-21 22G SAFETY IV CATHETER TO INSERT CLIENT'S IV TO HIS L-AC. DURING IV INSERTION, THIS RN OBSERVED A FLASH OF BLOOD IN THE TUBING OF THE IV CATHETER. TOURNIQUET WAS REMOVED AND THEN RN ADVANCED THE CATHETER SUCCESSFULLY INTO THE PATIENT'S VEIN. THE PATIENT HAS NO MEDICAL HISTORY AND IS HEALTHY. AS THE RN WAS RETRACTING THE NEEDLE, SHE OBSERVED A DROP OF BLOOD AT THE INSERTION SITE. THE NURSE ATTACHED THE PRIMED EXTENSION SET TO THE CATHETER, ATTEMPTED TO FLUSH, AND SUDDENLY THE PLASTIC CATHETER DISCONNECTED FROM THE TIP OF THE BLUE TRANSLUCENT HUB. UPON ASSESSMENT THERE WAS MILD REDNESS AND NO VISIBLE PLASTIC PRESENT AT INSERTION SITE, BUT STILL PALPABLE IN THE AREA. THE PATIENT WAS INSTRUCTED TO GO TO THE NEARBY HOSPITAL WHERE THEY REMOVED IT SURGICALLY AND STITCHED IT BUT NUMBER OF STITCHES NOT KNOWN. THE PATIENT REPORTED NO COMPLICATIONS AND DOING WELL AT THIS TIME. BATCH MANUFACTURING RECORDS: THE BATCH MANUFACTURING RECRODS (BMR) FOR THE REPORTED BATCH WERE REVIEWED. NO NON-CONFORMITIES RELATED TO THE COMPLAINT WERE OBSERVED. SUPPLIER VERIFICATION REPORTS: REPORTS WERE VERIFIDED FOR ANY SUPPLIER OR RAW MATERIAL CHANGES. NO CHANGES WERE INCORPORATED IN THE PROCESS OR MATERIALS. CONTROL SAMPLES: NO NON-CONFORMITIES RELTATED TO THE REPORTED COMPLAINT WERE OBSERVED DURING THE VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE CONTROL SAMPLES. THE FOLLOWING TESTS WERE PERFORMED ON THE CONTROL SAMPLES TO INVESTIGATE THE REPORTED COMPLAINT: VISUAL INPSECTION: NO VISUAL DEFECTS OBSERVED. PULL TEST OF THE CATHETER: OBSERVED WITHIN THE SPECIFICATION. LEAKAGE TEST: NO LEAKAGE OBSERVED IN THE PRODUCT. POSSIBLE ROOT CAUSES PER PRODUCTION TEAM: MANUFACTURING DEFECT: MAY BE DUE TO AN IMPROPER INSPECTION CARRIED OUT BY THE QUALITY INSPECTOR DURING THE IN-PROCESS STAGE. MAY BE AN INADEQUATE ASSEMBLY OF THE CATHETER WITH THE HUB. THE STRENGTH OF THE CATHETER MAY NOT MEET THE SPECIFIED REQUIREMENTS. USER ERROR: DEVICE MAY HAVE NOT BEEN USED AS INTENDED BY THE MANUFACTURER CATHETER MAY HAVE BEEN SEPARATED OR DEFORMED DUE TO MULTIPLE INSERTION ATTEMPTS/MISHANDLING BY THE END USER. THE CATHETER MIGHT HAVE BEEN PULLED OR TWISTED EXCESSIVELY DURING OR AFTER INSERTION. SUPPLIER PROVIDED CONCLUSION: BASED ON THE ROOT CAUSE ANALYSIS AND THE RESULTS OBTAINED FROM THE TESTS CARRIED OUT ON CONTROL SAMPLES OF THE REPORTED BATCH, IT IS CONCLUDED THAT THE PRODUCT DOES NOT CONTAIN A MANUFACTURING DEFECT. ALL CONTROL SAMPLES WERE FOUND TO BE ACCEPTABLE DURING VISUAL INSPECTION AND FUNCTIONAL TESTING. SINCE THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION, THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED OR REPRODUCED. THEREFORE, THE ROOT CAUSE OF THE COMPLAINT REMAINS UNDETERMINDED. HOWEVER, MOST LIKELY CAUSE IS USE-RELATED FACTORS, INCLUDING HANDLING DURING CLINICAL USE, MULTIPLE INSERTION ATTEMPTS, EXCESSIVE FORCE, OR DEVIATION FROM THE INSTRUCTIONS FOR USE (IFU), CANNOT BE RULED OUT AS POSSIBLE CONTRIBUTING FACTORS.