ARGYLE

Description of Event or Problem

"INCORRECT CONNECTORS FOR OUR 3.5FR SINGLE LUMEN UMBILICAL CATHETERS. THE HUB HAS TWO NOTCHES THAT DO NOT CONNECT WITH OUR SYRINGES OR TUBING. WHILE TRYING TO CONNECT THE LINE, THE PRACTITIONERS KEPT TURNING THE CATHETER BUT WERE UNABLE TO GET IT TO CONNECT PROPERLY. THERE ARE VARIOUS LOT NUMBERS ASSOCIATED WITH THE INCORRECT PRODUCT. CURRENTLY THERE ARE 25 CATHETERS ISOLATED, WHICH HAS DEPLETED OUR SUPPLY BY ABOUT HALF. 3.5FR UMBILICAL CATHETER PLACED. RN CONNECTING IVF'S, AFTER CONNECTING EXTENSION PIECE/TRI-FUSE, THE END WOULD NOT LOCK INTO PLACE TO THE END OF THE CATHETER, IT WOULD KEEP TURNING AND EASILY DISCONNECT. MULTIPLE EXTENSION TUBING TRIED AND THEY ALL DID THE SAME, WOULD NOT LOCK INTO CATHETER. INSPECTION OF THE CATHETER TIP SHOWED TO TABS, WHEN COMPARED WITH OTHER 3.5FR CATHETERS THOSE HAD TWO TABS AND A LIP. UMBILICAL CATHETER REPLACED, NO HARM TO PATIENT ONLY DELAY IN HANGING IVF'S AND A SECOND CATHETER BEING PLACED. TWIN B WAS GETTING LINES PLACED AT THE SAME TIME, CATHETER ASSESSED FOR THE SAME CATHETER TIP AND CHANGED PRIOR TO PLACEMENT. COVIDIEN ARGYLE, POLYURETHANE UMBILICAL VESSEL CATHETER, 3.5FR SINGLE LUMEN. LOT # NOT AVAILABLE. CATHETER SAVED. SWEEP OF UNIT DONE TO LOOK FOR OTHER SIMILAR CATHETER TIPS. GREAT CATCH FOR [REDACTED NAME] RN AND [REDACTED NAME] RN. PER CARDINAL REP ON [REDACTED DATE] THIS IS THE SECOND COMPLAINT THEY HAVE GOTTEN FROM A CUSTOMER IN OUR REGION IN THE LAST 24 HOURS. THEY HAVE OPENED A QA CASE AND ARE LOOKING FOR A ROOT CAUSE (THEY RECENTLY MADE MFG CHANGES TO ALIGN WITH ISO STANDARDS) AND SUPPLY THEIR CUSTOMERS WITH NON-IMPACTED LOT NUMBERS BUT HAVE TO IDENTIFY IMPACTED LOTS FIRST." MANUFACTURER RESPONSE FOR ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 3.5 FRENCH SINGLE LUMEN, ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 3.5 FRENCH SINGLE LUMEN (PER SITE REPORTER). PER CARDINAL REP ON [REDACTED DATE] THIS IS THE SECOND COMPLAINT THEY HAVE GOTTEN FROM A CUSTOMER IN OUR REGION IN THE LAST 24 HOURS. THEY HAVE OPENED A QA CASE AND ARE LOOKING FOR A ROOT CAUSE (THEY RECENTLY MADE MFG CHANGES TO ALIGN WITH ISO STANDARDS) AND SUPPLY THEIR CUSTOMERS WITH NON-IMPACTED LOT NUMBERS BUT HAVE TO IDENTIFY IMPACTED LOTS FIRST.