MAUDE Adverse Event Report: TELEFLEX (ARROW INTERNATIONAL) ARROW; MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION

Model Number IPN036437

Device Problems Unraveled Material (1664); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Er doctor had to use four different triple lumen cvc kits in order to place a central line due to the guidewire unraveling on two of the kits.1 kit the wire was bent and could not be manipulated.The triple lumen kits were contained within roi cps, llc kit 830024/unknown lot.

• Brand Name: ARROW
• Type of Device: MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION
• Manufacturer (Section D): TELEFLEX (ARROW INTERNATIONAL); 2400 bernville rd; reading PA 19605
• Manufacturer (Section G): TELEFLEX (ARROW INTERNATIONAL; 2400 bernville rd.; reading PA 19605
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4177303937
• MDR Report Key: 11205164
• MDR Text Key: 244017180
• Report Number: 3014527682-2021-00001
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 20801902117216
• UDI-Public: 20801902117216
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN036437
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F20C0330
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1