MAUDE Adverse Event Report: BOUND TREE MEDICAL, LLC CURAPLEX; KING LTS-D SUPRAGLOTTIC AIRWAY KIT

Model Number	KLTSD404K
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Ems service was responding to a cardiac arrest call and attempted to use the curaplex kit kltsd404k to care for the patient, but discovered the catheter tip of the syringe included to inflate the supraglottic airway was not compatible with the luer connector of the airway.As a result, the ems service was forced to seek other measures to establish an airway for the patient.No injuries or death were reported.

• Brand Name: CURAPLEX
• Common Device Name: KING LTS-D SUPRAGLOTTIC AIRWAY KIT
• Manufacturer (Section D): BOUND TREE MEDICAL, LLC; 1420 lakeside parkway; flower mound, tx
• MDR Report Key: 10089985
• Report Number: 3014680755-2020-00001
• Device Sequence Number: 17029391
• Product Code: CAE
• UDI-Device Identifier: 00812277033700
• UDI-Public: 00812277033700
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: KLTSD404K
• Device Catalogue Number: KLTSD404K
• Device Lot Number: ASM0025699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1