MAUDE Adverse Event Report: MEDLINE MEDLINE; PTCA KIT

Model Number	650108610
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The medline ptca kit was contained inside a convenience kit manufacturerd by our firm (roi cps, llc).Roi cps, llc submitted a customer complaint to medline on (b)(6) 2024 after receiving a customer complaint for the medline item contained in a convenience kit.A sample from the same lot reported by the end user was sent to medline for evaluation, root cause identification, and applicable corrective actions.On 2/26/2024 medline provided a closing response letter describing their investigation and the root cause of the issue they identified.The closing response letter from medline is attached (b)(4) closing response).Medline indicated that the event was likely caused by over pressurization of the closed system and provided a reference to the device ifu which defines the pressure levels that should not be exceeded while using the device.
Event or Problem Description
Staff noticed there is a leak in the y-connector on the ptca kit.The flush bag is leaking in to the waste bag.They believe the valve is incompetent.

• Brand Name: MEDLINE
• Common Device Name: PTCA KIT
• Manufacturer (Section D): MEDLINE; 10 glen falls technical park d; glens falls NY 12801
• Manufacturer (Section G): MEDLINE INDUSTRIES; 10 glen falls technical park d; glens falls NY 12801
• Manufacturer Contact: stephanie augsburg ; three lakes drive; northfield, IL 60093 ; 8476433690
• MDR Report Key: 18859478
• Report Number: 3014527682-2024-00010
• Device Sequence Number: 8282982
• Product Code: OEZ
• UDI-Device Identifier: 10193489074857
• UDI-Public: 10193489074857
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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: 650108610
• Device Catalogue Number: 650108910
• Device Lot Number: 0000101603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown