MAUDE Adverse Event Report: AVANOS - IRVINE ON-Q FIXED FLOW PUMP KITS WITH ON-Q SILVERSOAKER CATHETER; ELASTOMERIC LFR

Model Number PM028-A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot 0203130931 was reviewed and the product was produced according to product specifications.All information reasonably known as of 21 oct 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.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 complaint database and identified as complaint (b)(4).

Event Description

It was reported that when the patient was to have the catheters removed, one came out fine while the other one gave resistance, stretched, and broke.The surgeon was unable to visualize the fragment in an x-ray but estimates that the piece left in the patient is about an inch long.The patient will return the following week to have the piece removed.Per additional information received on 8 oct 2019, the patient has cerebral palsy and was unable to keep still during the catheter removal process.The surgeon feels that the catheter may have gotten caught on an internal screw.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 22 nov 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 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

One sample was received for evaluation.Visual inspection revealed that the catheter was significantly stretched.The catheter was broken and was missing the distal end.The missing distal end was not returned with the sample.Under magnification, the broken end was jagged and torn in appearance.Complaint was confirmed as reported.The root cause was determined to be use related, based on sample evaluation and information provided in the event description, where it was reported that the doctor met resistance, and the catheter was stretched and then broke.According to technical bulletin available to users, "if resistance is encountered during removal, or if the catheter stretches, stop continued pulling could break the catheter.It is advisable to cover the site with warm compress and, wait 30-60 minutes and try again.The patient¿s body movements may relieve the catheter to allow easier removal." all information reasonably known as of 07 jan 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 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 FIXED FLOW PUMP KITS WITH ON-Q SILVERSOAKER CATHETER
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9240860
• MDR Text Key: 214571654
• Report Number: 2026095-2019-00164
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651137211
• UDI-Public: 30680651137211
• 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: 01/08/2020

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: 04/29/2021
• Device Model Number: PM028-A
• Device Catalogue Number: 101372105
• Device Lot Number: 0203130931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 10/31/2019; 01/03/2020
• Supplement Dates FDA Received: 11/22/2019; 01/08/2020
• Patient Sequence Number: 1
• Patient Age: 16 YR