MAUDE Adverse Event Report: SUNMED AP, LTD. CURAPLEX; CURAPLEX BVM, ADULT, MASK SIZE 5, UNIVERSAL CONNECTOR, 7FT O2 TUBING

Model Number	301-BVM1500
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Code (a): 4756 (appropriate impact term/code not available): resuscitation bag w/mask.The product involved in the report has not been returned for evaluation.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 03/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 airlife represents all of the information known 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 provided by the user facility where the incident occurred.This product incident is documented in the airlife holdings complaint database and identified as complaint- (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 airlife product was defective or caused serious injury.
Event or Problem Description
It was reported that a plastic piece on the bag valve mask (bvm) broke off on several occasions, rendering the device unusable.No delay in therapy, harm, or injury was reported as a result of this event.
Event or Problem Description
It was reported that a plastic piece on the bag valve mask (bvm) broke off on several occasions, rendering the device unusable.No delay in therapy, harm, or injury was reported as a result of this event.
Additional Manufacturer Narrative
Code (a): 4756 (appropriate impact term/code not available): resuscitation bag w/mask the complaint product was not returned for physical evaluation; however, the reporter provided photographic evidence for review.Analysis of the submitted photo confirmed the reported defect.The investigation determined that the root cause was insufficient bonding strength of the upper cover.This condition was attributed to an inadequate height of the ultrasonic welding line, which resulted in incomplete or weakened bonding during assembly.Interim countermeasures (implemented (b)(6) 2025) reduced the upper limit of the welding height specification to increase welding strength and improve bond integrity.Implemented an additional in process inspection to verify tensile strength of the weld during production.Permanent countermeasure the design of the upper cover was modified to increase the height of the ultrasonic welding line.Mold adjustments have been completed, and verification activities are currently in progress to confirm effectiveness and process capability.A review of complaint history identified one complaint involving the same part number within 24 months.No additional trends were identified; monitoring will continue for any emerging trends.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 22 may 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 airlife represents all of the information known 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 provided by the user facility where the incident occurred.This product incident is documented in the airlife 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 airlife product was defective or caused serious injury.

• Brand Name: CURAPLEX
• Common Device Name: CURAPLEX BVM, ADULT, MASK SIZE 5, UNIVERSAL CONNECTOR, 7FT O2 TUBING
• Manufacturer (Section D): SUNMED AP, LTD.; 6-9 zhufeng rd., qiannan indus; qianwu town, doumen district; zhuhai guangdong, 51917 0; CH 519170
• Manufacturer (Section G): SUNMED AP, LTD.; 6-9 zhufeng rd., qiannan indus; qianwu town, doumen district; zhuhai guangdong, 51917 0; CH 519170
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 24246555
• Report Number: 1314417-2026-00007
• Device Sequence Number: 15867520
• Product Code: BTM
• UDI-Device Identifier: 00812277035322
• UDI-Public: (01)00812277035322
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 301-BVM1500
• Device Catalogue Number: 2442-BVM1500
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 05/22/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown