MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q FIXED FLOW PUMP KITS WITH ON-Q SILVERSOAKER CATHETER; CATHETERS

Model Number	PM025-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot 20013690 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 17 jun 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: 300 ml.Flow rate: unknown.Procedure: breast augmentation.Cathplace: breast.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the catheter broke during removal.Removal of the catheter piece was scheduled.No patient injury was reported.Additional information received 12-jun-2020 indicated "catheter removed, patient recovering fine but had to have second surgery to have it removed." patient was receiving 0.50% bupivacaine 300ml.".
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A photo of the device was provided by the customer and the reported incident was confirmed.However, the root cause could not be determined.All information reasonably known as of 27 jul 2020 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 avanos medical inc.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 avanos medical inc.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).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 avanos medical inc.Product is defective or caused serious injury.

• Brand Name: ON-Q FIXED FLOW PUMP KITS WITH ON-Q SILVERSOAKER CATHETER
• Common Device Name: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 10171904
• Report Number: 2026095-2020-00101
• Device Sequence Number: 1848200
• Product Code: MEB
• UDI-Device Identifier: 00193494137182
• UDI-Public: 00193494137182
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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 Expiration Date: 06/02/2022
• Device Model Number: PM025-A
• Device Catalogue Number: 101371804
• Device Lot Number: 20013690
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/29/2020
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 36