MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; INTRODUCER, CATHETER

Model Number	IPN036369
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During placement of arterial line, the sheath introducer was unable to penetrate skin; blue introducer possibly damaged at tip.No patient harm.Switched out for another device.

• Brand Name: ARROW
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 7266350
• Report Number: 7266350
• Device Sequence Number: 16578537
• Product Code: DYB
• UDI-Device Identifier: 10801902118919
• UDI-Public: (01)10801902118919
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2018
• Report Date (Section F): 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: IPN036369
• Device Catalogue Number: AK-09903-AG
• Device Lot Number: 13F17C0336
• Other Device ID Number: (17)180930 PROD NO. AK-09903-
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT BEING PREPPED FOR A CABG X4 PLACEMENT OF A
• Patient Age: 59 YR
• Patient Weight: 92
• Date Report Sent to FDA: 01/12/2018