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

Model Number PM025-A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 13-dec-2018 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: unknown.It was reported that a doctor experienced a catheter break incident after she pulled it out post-op day 3 after an abdominoplasty procedure.The catheter was severed at the 20 cm graduated mark.When it was pulled, it came out with no resistance.Additional information received on 03-dec-2018 stated that the doctor usually sutures the catheter to the skin to keep it from moving.Upon visual inspection of the catheter, it did appear to be stretched.No further information was provided.

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.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.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.

Manufacturer Narrative

The sample was returned broken.The returned catheter was examined and exhibited breakage.The broken part of the catheter was not returned with the sample.The evaluation summary concluded that the catheter was received broken into two pieces.Tensile strength was performed on the mid-body segment and met specifications.The breaking points exhibited whitish dried unknown materials inside the catheter tubing.Although the catheter was confirmed for breaking, the tensile strength on the mid-body segment of the catheter met the specifications.The root cause could not be determined.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 13-feb-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 PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS, 270 ML
• Type of Device: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8163831
• MDR Text Key: 131312022
• Report Number: 2026095-2018-00169
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651449499
• UDI-Public: 30680651449499
• 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,Followup,Followup
• Report Date: 02/08/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2020
• Device Model Number: PM025-A
• Device Catalogue Number: 101371800
• Device Lot Number: 0203010663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 12/27/2018; 02/08/2019
• Supplement Dates FDA Received: 01/24/2019; 02/18/2019
• Patient Sequence Number: 1