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

Model Number IPN036448

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2020

Event Type  malfunction  

Event Description

No patient harm: percutaneous sheath introducer - when opened in operating room it was noted the psi kit cath-gard for use with catheter was missing the tissue dilator.Another kit was opened and utilized.

• Brand Name: ARROW
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 9752974
• MDR Text Key: 180884253
• Report Number: 9752974
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 60801902116729
• UDI-Public: (01)60801902116729
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/31/2020

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
• Device Operator: Health Professional
• Device Model Number: IPN036448
• Device Catalogue Number: CDC-09903-1A
• Device Lot Number: 13F19J0012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1