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

Model Number #477KLTSD4125

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2020

Event Type  Injury  

Event 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
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIIOLOGY
• Manufacturer (Section D): BOUND TREE MEDICAL, LLC
• MDR Report Key: 9774578
• MDR Text Key: 181781686
• Report Number: MW5093396
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 00817617020549
• UDI-Public: (01)00817617020549
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability