MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PUMP FIXED FLOW; KITS

Model Number	PS6502-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 27 may 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical inc.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 avanos medical inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
Fill volume: unknown, flow rate: unknown, procedure: c-section, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.It was reported that "when the customer removed the catheter from a patient, the catheter was cut and a part of catheter was remained in body.So they took an x-ray to find the part but they couldn¿t see it in x-ray." additional report stated "a silver soaker catheter broke when it was being removed from a patient.The healthcare professional was not able to locate the remaining part via an x-ray." additional information received 12-may-2020 indicated "in the process of removing the catheter, after c-section, small portion of the catheter left in patient.So, hospital took x-ray to find catheter, but catheter is too small to find.In this issue, doctor keep monitoring patient's condition.There is no problem with the patient's condition now." the catheter was inserted through a steel needle and was connected to an on-q ondemand infusion pump.

• Brand Name: ON-Q PUMP FIXED FLOW
• Common Device Name: KITS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10097247
• Report Number: 2026095-2020-00073
• Device Sequence Number: 14304599
• Product Code: MEB
• UDI-Device Identifier: 10680651136272
• UDI-Public: 10680651136272
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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: PS6502-A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 05/28/2020
• Patient Sequence Number: 1