MAUDE Adverse Event Report: BOUND TREE MEDICAL, LLC CURAPLEX; CURAPLEX SMALL ADULT/PEDIATRIC PREMIUM BVM W/ BAG RESERVOIR, MANOMETER, 25CM POP

Model Number	AF2000
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The disk on the bottom that acts as a one-way valve came loose and was found in the bag.This caused a lack of positive pressure resulting in a delay of resuscitation efforts for the patient.The patient is in critical care on a ventilator currently.The failure was noted quickly, and a replacement was used from a backup on the ambulance.
Event or Problem Description
The disk on the bottom that acts as a one-way valve came loose and was found in the bag.Failure was on an ambulance.The unit failure resulted in lack of positive pressure.The airway emt noticed this and changed to another unit that in fact operated correctly.The etco2 improvement was dramatic.
Event or Problem Description
The disk on the bottom that acts as a one-way valve came loose and was found in the bag.Failure was on an ambulance.The unit failure resulted in lack of positive pressure.The airway emt noticed this and changed to another unit that in fact operated correctly.The etco2 improvement was dramatic.
Additional Manufacturer Narrative
The disk on the bottom that acts as a one-way valve came loose and was found in the bag.This caused a lack of positive pressure resulting in a delay of resuscitation efforts for the patient.The patient is in critical care on a ventilator currently.The failure was noted quickly, and a replacement was used from a backup on the ambulance.**udi related data quality updates** in addition, investigation was completed with the following updates: the complaint of "the disk on the bottom that acts as a one-way valve came loose and was found in the bag." regarding part number 2442-bvmpsa/lot 363395 was not confirmed as there was no returned product, pictures or video to evaluate.This complaint could potentially be related to a loose diaphragm valve within the bag body that was not assembled correctly and became loose prior to end-use.The device history record (dhr) review showed no abnormal processing issues noted related to this complaint; the tail valve assembly (pn 3010007) was from lot numbers 220700087 and 220600023, and those lots passed inspection.A risk assessment was performed, and the ultimate risk was determined to be high which does require reporting to the capa review board; the complaint was submitted to carb.There have been zero (0) other complaints regarding part number 2442-bvmpsa for the same issue within the 24 months preceding the reporting of this issue.A memo, containing the complaint investigation, was sent to the customer.Complaints will continue to be monitored for possible trends.

• Brand Name: CURAPLEX
• Common Device Name: CURAPLEX SMALL ADULT/PEDIATRIC PREMIUM BVM W/ BAG RESERVOIR, MANOMETER, 25CM POP
• Manufacturer (Section D): BOUND TREE MEDICAL, LLC; 5000 tuttle crossing blvd; dublin OH 43016
• Manufacturer (Section G): WESTMED JAVID DE MEXICO, S.A. DE C.V; carretera internacional km 6.5; edif 18; parque industrial nog; nogales sonora, mexico OH 84094 ; MX 84094
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18377722
• Report Number: 1314417-2023-00030
• Device Sequence Number: 20737256
• Product Code: BTM
• UDI-Device Identifier: 00812277037029
• UDI-Public: (01)00812277037029
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AF2000
• Device Catalogue Number: 2442-BVMPSA
• Device Lot Number: 363395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown