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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation a review of the device history record is in-progress.All information reasonably known as of 07 oct 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings complaint database and 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 an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported: the bag-valve-mask (bvm) had a failure on the pop off valve, during patient use, the white top to the valve broke off.There was no reported injury.
Event or Problem Description
It was reported: the bag-valve-mask (bvm) had a failure on the pop off valve, during patient use, the white top to the valve broke off.There was no reported injury.
Additional Manufacturer Narrative
Correction: d9.Additional information-investigation completion: d4; h2; h6.The actual sample from the reported event was returned for evaluation.Visual examination of the device was performed as well as manual manipulation.The reported event could be confirmed as reported; the root cause was determined to be a chemical reaction, which occurred during the manufacturing process, that lead to the release of internal stress in the elbow/housing, resulting in the formation of cracks and/or fractures.A trend analysis was performed and one (1) other complaint was found, regarding the 'pop off valve// broke', within the 24 months preceding this reported event; complaints will continue to be monitored for possible trends.The device history record for lot 526970 was reviewed and the product was produced according to product specifications.All information reasonably known as of 06 feb 2026 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings complaint database and 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 an sun med holdings llc.Product is defective or caused serious injury.

• 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): SUN MED; productos urologos de mexico s; no. 85 parque indus. mexicali; mexicali baja california, mx ; MX
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 23238705
• Report Number: 1314417-2025-00078
• Device Sequence Number: 21340654
• Product Code: BTM
• UDI-Device Identifier: 00812277037029
• UDI-Public: (01)00812277037029(10)526970(17)290115(11)241220
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 02/06/2026

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: 526970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown