MAUDE Adverse Event Report: SUNMED AP, LTD. CURAPLEX; ADULT ORAL-NASAL 7FT ETCO2 FITS-ALL REFLECTIVE CONNECTOR

Model Number	5707F-SE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Health effect-clinical code: (appropriate health impact term/code not available): unspecified life-threatening injury to the patient.No additional information was provided.The product involved in the report has not been returned for evaluation.A review of the device history record is not possible as no lot number was provided.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided all information reasonably known as of 15 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
It was reported, the tube that goes into the gas bench from the connector broke off and created an unspecified life-threatening injury to the patient.The monitor was changed; no additional information was provided.
Event or Problem Description
It was reported, the tube that goes into the gas bench from the connector broke off and created an unspecified life-threatening injury to the patient.The monitor was changed; no additional information was provided.It was additionally reported, the unit(s) went down due to over-torque.The middle of the connector snapped when turned too far.
Additional Manufacturer Narrative
Correction: b5; h6.Additional information investigation conclusion: h6.Health effect-clinical code: (appropriate health impact term/code not available): unspecified life-threatening injury to the patient.No additional information was provided.The product involved in the report was not returned for evaluation; however, the reporter did provide a photograph of the reported issue.The complaint is confirmed as reported.The root cause was determined to be user error.A review of the device history record is not possible as no lot number was provided.The documented udi is based on the stock/product code provided by the reporter.The udi-pi is not available as no lot number was provided.All information reasonably known as of 29 jul 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 21 cfr 803, 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: ADULT ORAL-NASAL 7FT ETCO2 FITS-ALL REFLECTIVE CONNECTOR
• Manufacturer (Section D): SUNMED AP, LTD.; 6-9 zhufeng rd., qiannan indus; qianwu town, doumen district; zhuhai guangdong, ch 51917 0; CH 519170
• 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: 22031560
• Report Number: 1314417-2025-00026
• Device Sequence Number: 8503593
• Product Code: CCK
• UDI-Device Identifier: 00810071631696
• UDI-Public: (01)00810071631696
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 5707F-SE
• Device Catalogue Number: 301-5707F-SE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown