MAUDE Adverse Event Report: MEDLINE INDUSTRIES MEDLINE; NEB,REUSEABLE CUP,T-CONN,MP,7'TUBING

Model Number	HCS4482R
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint product was not returned for evaluation; however, the reporter provided photographic evidence.The submitted images do not depict the reported issue; therefore, the complaint could not be confirmed.The root cause could not be determined.A review of complaint history identified no similar complaints involving the same part number and failure mode within the preceding 24 months.No additional trends were identified; monitoring will continue for any emerging trends.The part number is obsolete, and the associated device history records (dhrs) have exceeded the five-year retention period and are no longer available.The product number was originally unknown; therefore, the initial report was submitted under report 3006606984-2026-00001.However, the product number has since been received, and this submission serves as the new report, including the investigation findings.All information related to this case will be captured under this record.A follow-up will not be submitted for report 3006606984-2026-00001.All information reasonably known as of 28 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 is defective, caused, or contributed to a serious injury.
Event or Problem Description
It was reported that the meddelivery tubing repeatedly disconnected during treatment.No delay in therapy, harm, or injury was reported as a result of this event.

• Brand Name: MEDLINE
• Common Device Name: NEB,REUSEABLE CUP,T-CONN,MP,7'TUBING
• Manufacturer (Section D): MEDLINE INDUSTRIES; 3 three lakes dr; northfield IL 60093
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V; cerrada via de la produccion; no. 85 parque indust. mexicali; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 25325782
• Report Number: 1314417-2026-00034
• Device Sequence Number: 9806257
• Product Code: CAF
• UDI-Device Identifier: 10080196418329
• UDI-Public: (01)10080196418329(10)082015N21
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K070948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: HCS4482R
• Device Catalogue Number: HCS4482R
• Device Lot Number: 082015N21
• 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: 05/01/2026
• Initial Report FDA Received Date: 05/28/2026
• 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