Additional Manufacturer Narrative · 1
LOT HISTORY RECORD REVIEW: THE LOT HISTORY RECORDS WERE REVIEWED FOR ANY ABNORMALITIES THAT MAY HAVE CONTRIBUTED TO THE CAUSE OF THE COMPLAINT. NOTHING KNOWN TO HAVE CONTRIBUTED TO THE COMPLAINT WAS OBSERVED. REVIEW OF RETURNED SAMPLE: THE INFO SUPPLIED FROM THE FDA STATES THE SAMPLE IS AVAILABLE FOR EVAL, BUT TO DATE THE SAMPLE HAS NOT YET BEEN RECEIVED. ATTEMPTS TO OBTAIN THE SAMPLES HAVE BEEN UNSUCCESSFUL. THE SALES REP SEEMS TO BELIEVE THIS COMPLAINT IS A DUPLICATE OF ONE OF THE OTHER COMPLAINTS THE COMPLAINANT HAS SUBMITTED AND THAT THE SAMPLE HAS ALREADY BEEN RETURNED. HOWEVER, THE CATALOG NUMBER AND LOT NUMBER DID NOT MATCH UP WITH THE OTHER COMPLAINTS. CONCLUSION THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVAL. WITHOUT THE ACTUAL SAMPLE ANGIODYNAMICS IS UNABLE TO CONDUCT A THOROUGH INVESTIGATION. THE CAUSE OF THE COMPLAINT IS UNK. A POSSIBLE CAUSE OF THIS COMPLAINT TYPE IS THE CATHETER COMING IN CONTACT WITH SHARP INSTRUMENT. ALL CATHETERS ARE 100% LEAK TESTED BEFORE RELEASE, THIS TYPE OF COMPLAINT WOULD HAVE BEEN OBSERVED AT THAT PROCEDURE. A REVIEW OF THE MFG RECORDS FOR THE REPORTED LOT INDICATED THAT ALL OF THE DEVICE SPEC AND QUALITY REQUIREMENTS WERE SATISIFIED. THE INSTRUCTIONS FOR USE HAVE THE FOLLOWING WARNINGS STATED TO AVOID THIS TYPE OF COMPLAINT FROM OCCURRING: DO NOT ALLOW DEVICE CONTACT WITH SHARP INSTRUMENT. MECHANICAL DAMAGE MAY OCCUR. USE ONLY SMOOTH EDGED, ATRAUMATIC CLAMPS OR FORCEPS. DO NOT PLACE SUTURE AROUND THE CATHETER. SUTURES MAY DAMAGE THE CATHETER OR COMPROMISE CATHETER PATENCY. ACCESSORIES AND COMPONENTS WITH LUER LOCK CONNECTIONS SHOULD BE USED WITH THIS DEVICE. 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.