MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) JACC; CENTRAL VENOUS ACCESS CATHETER

Model Number ARROW CG+ 6FR

Device Problems Hole In Material (1293); Split (2537); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2015

Event Type  malfunction  

Event Description

A triple lumen jacc catheter was placed in the patient without incident; used multiple times, flushed and exhibited good blood return.The patient went to undergo a ct scan; contrast was injected to the functional power rated red port (after blood return & flush without incident).After the injection of the contrast, the patient reported "feeling wet".Ct staff inspected and there was pooling of contrast under clear dressing and external to dressing.There was no harm to patient or infiltration observed.The line was promptly removed.There is a large visible hole in the catheter now.Given the prior functionality, it would appear this evolved at the time of injection at ct.It is not a clean split.The catheter also appears as if it may have been twisted.If this were to be the case, it would prevent the forceful contrast from entering, thereby leading to the large hole in the catheter as it seeks to escape.

• Brand Name: JACC
• Type of Device: CENTRAL VENOUS ACCESS CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); 2400 bernville road; reading PA 19605
• MDR Report Key: 4915055
• MDR Text Key: 6435773
• Report Number: 4915055
• Device Sequence Number: 1
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: ARROW CG+ 6FR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 127