MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q EXPANSION KITS WITH SOAKER CATHETER, SOAKER 1 IN. (2.5 CM); CATHETERS

Model Number	PM030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure: unknown.Cathplace: unknown.It was reported that the infusion was inserted and ran without issue.Upon removal, the catheter appeared to have snapped and the distal 5cm of catheter was missing.Patient's current status was listed as "ok - discharged home." additional information received 25-mar-2021 indicated a decision was made to not do anything about the retained part of the catheter.A scan was performed which did not suggest any problems related to the catheter and the patient was discharged as usual.
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 13 apr 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).
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.A slight kink was observed approximately 9.5cm below the base of the hub and the severed end was slightly jagged.When viewed directly at the tip, it also appeared pinched.Root cause could not be determined.All information reasonably known as of 12 may 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 EXPANSION KITS WITH SOAKER CATHETER, SOAKER 1 IN. (2.5 CM)
• Common Device Name: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11660892
• Report Number: 2026095-2021-00052
• Device Sequence Number: 16868759
• Product Code: BSO
• UDI-Device Identifier: 00193494135379
• UDI-Public: 00193494135379
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K043456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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 Model Number: PM030
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 73