Additional Manufacturer Narrative · 1
LOT HISTORY RECORD REVIEW: THE LOT NUMBER WAS NOT PROVIDED, A SHIP HISTORY WAS CONDUCTED AND SHOWED THE FACILITY HAD NOT RECEIVED ANY OF THE REPORTED CATALOG NUMBER SINCE GOING TO SAP IN 11/05. VERIFIED INFO STATED THE ORIGINAL ANGIODYNAMICS EXPIRATION DATE WAS 8/1/03. ADDITIONAL INFO ALSO STATED THE CATHETER WAS REPROCESSED AT ALLIANCE MEDICAL CORP AND THAT AFTER REPROCESSING THERE IS NO EXPIRATION DATE AS LONG AS THE PACKAGING SEAL IS NOT BROKEN. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVAL. THE MAUDE REPORT INDICATED THE SAMPLE IS AVAILABLE FOR EVAL; HOWEVER, DURING A PHONE CALL WITH FACILITY, SHE STATED IT WAS NOT THEIR POLICY TO RETURN THE SAMPLE. CONCLUSION: THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVAL. WITHOUT THE COMPLAINT SAMPLE, ANGIODYNAMICS IS UNALE TO CONDUCT A THOROUGH INVESTIGATION. BASED ON THE INFO PROVIDED, IT APPEARS THE CAUSE OF THE COMPLAINT IS DUE TO THE REPROCESSING OF THE CATHETER. IT HAS BEEN CONFIRMED THE PRODUCT WAS USED AFTER THE EXPIRATION DATE AND HAD BEEN REPROCESSED AT ALLIANCE MEDICAL CORP. THE INSTRUCTIONS FOR USE AND PRODUCT PACKAGING STATE: SINGLE USE - DO NOT RESTERILZE. STORE IN A COOL DRY PLACE. PROTECT FROM UV LIGHT. EXPIRATION DATE 8/03. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION AT THIS TIME. FREQUENCY HAS INCREASED BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.