MAUDE Adverse Event Report: BOUND TREE MEDICAL, LLC CURAPLEX; ADULT 7FT ETCO2 GAS SAMPLING LINE WITH ET-TUBE ADAPTER

Model Number	5107ET
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 28 mar 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 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 an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced six different incidences, which were associated with separate units, involving six different patients.This is the fourth of six reports.Refer to 1314417-2025-00017 for the first report.Refer to 1314417-2025-00018 for the second report.Refer to 1314417-2025-00019 for the third report.Refer to 1314417-2025-00021 for the fifth report.Refer to 1314417-2025-00022 for the sixth report.It was reported, when the zoll monitor was applied to the non- intubated patient no data displayed (no reading and/ or respiratory rate), which lead to a delay and difficulty in gathering vital signs to assess breathing.The capno lines were changed; there was no reported injury.
Additional Manufacturer Narrative
Correction: g1.Additional information: d4; h6.Video evidence provided by the reporter was reviewed and confirmed the event as reported.The root cause was determined to be user error.The device history record for lot 240100249 was reviewed and the product was produced according to product specifications.All information reasonably known as of 22 may 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
Sunmed holdings llc.Received a single report that referenced six different incidences, which were associated with separate units, involving six different patients.This is the fourth of six reports.Refer to 1314417-2025-00017 for the first report.Refer to 1314417-2025-00018 for the second report.Refer to 1314417-2025-00019 for the third report.Refer to 1314417-2025-00021 for the fifth report.Refer to 1314417-2025-00022 for the sixth report.It was reported, when the zoll monitor was applied to the non- intubated patient no data displayed (no reading and/ or respiratory rate), which lead to a delay and difficulty in gathering vital signs to assess breathing.The capno lines were changed; there was no reported injury.

• Brand Name: CURAPLEX
• Common Device Name: ADULT 7FT ETCO2 GAS SAMPLING LINE WITH ET-TUBE ADAPTER
• Manufacturer (Section D): BOUND TREE MEDICAL, LLC; 5000 tuttle crossing inc.; dublin OH 43016
• Manufacturer (Section G): SUNMED AP, LTD.; 6-9 zhufeng rd., qiannan indus; qianwu town, doumen district; zhuhai guangdong, ch 51917 0; CH 519170
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 21720233
• Report Number: 1314417-2025-00020
• Device Sequence Number: 19815600
• Product Code: CCK
• UDI-Device Identifier: 00810071631863
• UDI-Public: (01)00810071631863(10)240100249(17)290102(11)240102
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063813
• 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): 05/22/2025

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: 5107ET
• Device Catalogue Number: 301-5107ET
• Device Lot Number: 240100249
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2024
• 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