MAUDE Adverse Event Report: TRIMED, INC PEG-XTNDR

Model Number	PEG-XTNDR
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2018, it was reported, by a trimed sales rep, that a peg-xtndr in his set were showing rust around the spring.The rep reported that this feedback was not associated with a clinical event, and there was no patient involvement.This is the sixth complaint of this kind for this type of part.

• Brand Name: PEG-XTNDR
• Common Device Name: PEG-XTNDR
• Manufacturer (Section D): TRIMED, INC; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 7261847
• Report Number: 2031009-2018-00008
• Device Sequence Number: 987277
• Product Code: LXH
• UDI-Device Identifier: 00842188112867
• UDI-Public: 00842188112867
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2018

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: Health Professional
• Device Model Number: PEG-XTNDR
• Device Catalogue Number: PEG-XTNDR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1