MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE; INTRODUCER, CATHETER

Model Number	RSB602
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Hair found in package.

• Brand Name: PINNACLE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 17850557
• Report Number: 17850557
• Device Sequence Number: 14300384
• Product Code: DYB
• UDI-Device Identifier: 00389701007564
• UDI-Public: (01)00389701007564(17)250701(10)0000279073
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/26/2023
• Report Date (Section F): 06/26/2023

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: Other
• Device Model Number: RSB602
• Device Catalogue Number: RSB602
• Device Lot Number: 0000279073
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/26/2023