MAUDE Adverse Event Report: SALTER LABS PARKER H-PTCL-30 THIN CUFF; TRACHEAL TUBE

Model Number	H-PTCL-30
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial and final report.Actual device not returned, unable to verify complaint.No injury occurred.
Event or Problem Description
Customer reports that the pilot cuff and tube became disconnected from the body of the endotracheal tube.Et tube was changed out successfully.No patient injury was reported.

• Brand Name: PARKER H-PTCL-30 THIN CUFF
• Common Device Name: TRACHEAL TUBE
• Manufacturer (Section D): SALTER LABS; 2365 camnio vida roble; carlsbad CA 92011
• MDR Report Key: 7207081
• Report Number: 3000219639-2018-00002
• Device Sequence Number: 1173491
• Product Code: BTR
• UDI-Device Identifier: 10749065161307
• UDI-Public: 10749065161307
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2018

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: Other
• Device Expiration Date: 06/28/2022
• Device Model Number: H-PTCL-30
• Device Catalogue Number: H-PTCL-30
• Device Lot Number: 1707CL1334C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2018
• Initial Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1