MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q EXPANSION KITS WITH SOAKER CATHETER, 5 IN. (12.5 CM) / NEEDLE 6 IN X 17 G

Model Number	PM020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 08-jan-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: unknown.Cathplace: unknown.It was reported while removing the sheath the physician noticed the tip had come off, about 2cm.The physician had to explore part of the incision where the catheter was and remove the tip that broke off.The catheter was replaced with a new onq catheter.
Event or Problem Description
Procedure: radical laparoscopic nephrectomy.Procedure date: (b)(6) 2020.Additional information received 20-jan-2021 stating the catheter was not sutured, this was the initial insertion at end of case.The catheter was inserted into soft tissue.The drug was not a contributor or potential contributor to the reported incident.
Additional Manufacturer Narrative
The device history record for the reported lot number, 20015344, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 11-feb-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 comp-ghc-20-03615.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 EXPANSION KITS WITH SOAKER CATHETER, 5 IN. (12.5 CM) / NEEDLE 6 IN X 17 G
• Common Device Name: KITS
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11142799
• Report Number: 2026095-2021-00006
• Device Sequence Number: 3596206
• Product Code: BSO
• UDI-Device Identifier: 10680651135343
• UDI-Public: 10680651135343
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K043456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: 05/13/2022
• Device Model Number: PM020
• Device Catalogue Number: N/A
• Device Lot Number: 20015344
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/12/2021
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 34