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

Model Number	IPN037390
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The anesthesia care technician reported opening a psi kit and finding a rusted clamp.There are two glass vials in the kit.One was empty and the other completely broken which we presume caused the clamp to rust.This is the second event within this lot number.It is unclear whether this was a shipping and transport issue or a storage issue.The vendor has been notified.This is a specialty kit made for this facility, so this may not present an issue for other sites.

• Brand Name: ARROW
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 6550 wedgwood rd. n.; suite 300; maple grove MN 55311
• MDR Report Key: 7221039
• Report Number: 7221039
• Device Sequence Number: 1847509
• Product Code: DYB
• UDI-Device Identifier: 10801902124323
• UDI-Public: (01)10801902124323(17)200131(10)13F17F0363
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 01/23/2018
• Report Date (Section F): 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: IPN037390
• Device Catalogue Number: ASK-01409-JHH
• Device Lot Number: 13F17F0363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Date Report Sent to FDA: 01/23/2018