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 Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 14 nov 2025 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and is identified as (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a airlife product is defective or causes serious injury.
Event or Problem Description
It was reported the device experienced a malfunction that inhibited proper ventilation of a patient, specifically, the pop-off valve component, located between the bag and the manometer, became dislodged from the bag valve mask (bvm).There was no report of delay in therapy, harm or injury as a result of this report.
Event or Problem Description
It was reported the device experienced a malfunction that inhibited proper ventilation of a patient, specifically, the pop-off valve component, located between the bag and the manometer, became dislodged from the bag valve mask (bvm).There was no report of delay in therapy, harm or injury as a result of this report.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 14 nov 2025 has been included in the health authority report.Should additional.Information be obtained a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and is identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a airlife product is defective or causes serious injury.The complaint of "pop-off valve.Had become dislodged from the bvm" regarding part 2442-bvmpsa was confirmed.The root cause was determined to be the plasticizer leaches from the orange tethered reacted with the dichloromethane glue, the pop-off housing, and the hyperinflation elbow.This chemical reaction led to the release of internal stress in the elbow/housing, resulting in the formation of cracks or even fractures.A risk assessment was performed, and the ultimate risk was determined to be medium but does not require escalation to the capa review board.There have been 3 other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.The ultimate risk is medium, as that is the highest risk of the patient/caregiver and regulatory/compliance considerations: 1.Patient/caregiver performed risk assessment with (b)(6) revision 2; the most closely associated risk is id (b)(4) (p1=1, p2=1) with a probability of harm occurring p=1 and severity s=5 which is medium risk.(b)(4).Therefore, the probability of harm occurring (p) remains the same as the rma and is determined to be medium risk per (b)(4) rev2.2.Regulatory/ compliance reviewed (b)(4) rev2, and there is low regulatory/ compliance risk.3.Brand recognition and customer impact reviewed (b)(4) rev2, and there is medium brand recognition/customer impact.

• 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 inc.; 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 84094 ; MX 84094
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 23563137
• Report Number: 1314417-2025-00096
• Device Sequence Number: 10081803
• Product Code: BTM
• UDI-Device Identifier: 00812277037029
• UDI-Public: (01)00812277037029(10)0004329932
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: AF2000
• Device Catalogue Number: 2442-BVMPSA
• Device Lot Number: UNKNOWN
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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