MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number IPN036474

Device Problems Kinked (1339); Difficult To Position (1467)

Patient Problem No Information (3190)

Event Date 02/28/2018

Event Type  malfunction  

Event Description

Icu staff obtained and opened a new multi-lumen central venous catheter (cvc) kit and they noticed that the 7fr 20cm agb+ blue cather was kinked/crooked and would not allow j-guide wire to be passed thru.Staff did not use device on patient and grabbed another multi-lumen cvc kit to complete procedure.

• Brand Name: ARROW
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 11245 n distribution cove; olive branch MS 38654
• MDR Report Key: 7330171
• MDR Text Key: 102079733
• Report Number: 7330171
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902117202
• UDI-Public: (01)10801902117202
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: IPN036474
• Device Catalogue Number: CDC-45703-PB1A
• Device Lot Number: 13F17L0099
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER DEVICES USED, OPENED FROM NEW PACK