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

Model Number	IPN036755
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Before a picc insertion, the nurse trimmed the catheter to a measurement of 43 cm.During the process, the nurse pulled the sensor back a little to prevent damaging the former one during the setup of the catheter.After the catheter was trimmed, the nurse had trouble advancing the sensor getting stuck inside the catheter.The nurse decided to use another picc kit and restart the process.

• Brand Name: ARROW
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10249978
• Report Number: 10249978
• Device Sequence Number: 689597
• Product Code: LJS
• UDI-Device Identifier: 80801902123745
• UDI-Public: (01)80801902123745
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2020
• Report Date (Section F): 07/02/2020

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
• Operator of Device: Health Professional
• Device Model Number: IPN036755
• Device Catalogue Number: CDC-35052-VPS
• Device Lot Number: 23F19M0292
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 45
• Date Report Sent to FDA: 07/02/2020