MAUDE Adverse Event Report: BOUND TREE MEDICAL, LLC CURAPLEX; AIRWAY, OROPHARYNGEAL, ANESTHESIIOLOGY

Model Number	#477KLTSD4125
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Curaplex supraglotic airway kit, king lts-d, size 2.5, 25-35kg #477-kltsd4125 (lot #asm0021574) contains: (1) supraglotic airway, king lts-d size 2.5 (1) syringe only, 10 oc luer lock (1) gastric tube, 16fr (1) packet of lubricating jelly.The manufacturer (ambu) of the king airway lts-d recommends an inflation volume of 30-40 cc for the device and the packaged product from the manufacturer comes with a syringe sized to support this volume.The 10 cc syringe found in the curaplex kit with the same king airway device could result in an under-inflated balloon if the user does not re-load the syringe with air 3-4 times.An under-inflated balloon could lead to device failure resulting in hypoxia and if untreated death.Curaplex product by samova hc.Llc's family of companies: bound tree medical llc.Cardic partners, inc.Emergency medical products, inc.& tri-anim health services inc.Distributor: (b)(4).Fda safety report id # (b)(4).

• Brand Name: CURAPLEX
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTHESIIOLOGY
• Manufacturer (Section D): BOUND TREE MEDICAL, LLC
• MDR Report Key: 9774578
• Report Number: MW5093396
• Device Sequence Number: 11376651
• Product Code: CAE
• UDI-Device Identifier: 00817617020549
• UDI-Public: (01)00817617020549
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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 Expiration Date: 06/30/2020
• Device Model Number: #477KLTSD4125
• Device Catalogue Number: 477-KLTSD4125
• Device Lot Number: ASM0021574
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability