MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q EXPANSION KITS WITH SILVERSOAKER CATHETER 10 IN (25 CM), NEEDLE 8 IN.X17GA; CATHETERS

Model Number	PM040-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional 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 not possible as no lot number was provided.The lot number provided incorrect.All information reasonably known as of 02-apr-2019 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 the on-q catheter broke in-situ during an attempted removal.The patient was taken back to surgery where the remaining part of the catheter was removed, approximately 27cm in length.There was no reported complications from the procedure.No additional information was provided.
Additional Manufacturer Narrative
One used sample was received.The device was evaluated.The catheter was received in two segments.Both segments exhibited stretching.The root cause was not identified.All information reasonably known as of (b)(6)-2019 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 EXPANSION KITS WITH SILVERSOAKER CATHETER 10 IN (25 CM), NEEDLE 8 IN.X17GA
• Common Device Name: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8477172
• Report Number: 2026095-2019-00048
• Device Sequence Number: 1019024
• Product Code: BSO
• UDI-Device Identifier: 30680651135392
• UDI-Public: 30680651135392
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: PM040-A
• Device Catalogue Number: 101353900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 06/10/2019
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 37