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

Model Number	IPN037388
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A guide wire shredded while cannulating the patient.Two (2) cvc kits were used and the user is uncertain which kit the problem guide wire came from.Fda safety report id# (b)(4).

• Brand Name: ARROW PI MULTI LUMEN CVC KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; reading PA 19610
• MDR Report Key: 9962091
• Report Number: MW5094132
• Device Sequence Number: 14149407
• Product Code: FOZ
• UDI-Device Identifier: 10801902124958
• UDI-Public: 10801902124958
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/10/2020
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 02/28/2021
• Device Model Number: IPN037388
• Device Catalogue Number: ASK-15703-PHH
• Device Lot Number: 13F19K0217
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 99