MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q CATHETERS-SILVERSOAKER

Model Number	PM010-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
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.All information reasonably known as of 20 may 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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the catheter was "found broken while patient was in bed ¿ not when attempting to remove the catheter.The catheter was a matthew¿s placement by the orthopedic surgeon on monday, (b)(6) 2019 and therapy was to last until approximately thursday.Remainder of catheter removed without harm to patient.Nothing retained in the patient".Additional information received the same day indicated "post op [post-operative] day one bilateral total knee [the surgeon's] patient on the floor 24 hour postop remainder of catheter fully removed from patient.Nothing left inside the patient.Found broken, not during any attempt to remove catheter from patient.The patient still has the catheter and pump with his other knee".
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.One used catheter was received in two segments.No product packaging was received and the product does not contain a lot number identification.The catheter is severed 1.5" from the proximal end.The distal segment measures 25.5".The black tip is intact and attached at the distal end.The severed ends were examined under magnification.The ends are jagged and there is no visible stretching.There are two distinct crimps in the distal segment.One crimp is located approximately 4.5" from the severed end and the other approximately 11.75" from the severed end.The root cause could not be identified.All information reasonably known as of 22 jul 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 halyard health 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 CATHETERS-SILVERSOAKER
• Common Device Name: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8628896
• Report Number: 2026095-2019-00091
• Device Sequence Number: 11254919
• Product Code: BSO
• UDI-Device Identifier: 10680651135336
• UDI-Public: 10680651135336
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K051401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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: PM010-A
• Device Catalogue Number: 101353302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1