MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS 270 ML; KITS

Model Number PM025-A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned, and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 18-dec-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 Description

Fill volume: unknown; flow rate: unknown; procedure: abdominoplasty; cathplace: abdomen.It was reported, "the catheter broke off", when the clinician was removing the device from the patient.It was noted the broken device component would be removed from the patient when the incision heals.There was no reported injury.

Manufacturer Narrative

The device history record for the reported lot number: 30039240, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One catheter was received in two segments.The device was evaluated and the reported failure was confirmed.A root cause was not identified.All information reasonably known as of 21-jan-2021 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 PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS 270 ML
• Type of Device: KITS
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11046912
• MDR Text Key: 222740882
• Report Number: 2026095-2020-00185
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494137182
• UDI-Public: 00193494137182
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 12/21/2020

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
• Device Operator: Health Professional
• Device Model Number: PM025-A
• Device Catalogue Number: N/A
• Device Lot Number: 30039240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/21/2020
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 81