• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q EXPANSION KITS WITH SILVERSOAKER CATHETER 10 IN (25 CM), NEEDLE 8 IN. X 17; CATHETERS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AVANOS MEDICAL, INC. ON-Q EXPANSION KITS WITH SILVERSOAKER CATHETER 10 IN (25 CM), NEEDLE 8 IN. X 17; CATHETERS Back to Search Results
Model Number PM040-A
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/23/2020
Event Type  malfunction  
Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 08 oct 2020 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: vat [video-assisted thoracoscopy].Cath.Place: between pleura and ribs.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the tip broke off of a silver soaker catheter after difficult removal.The tip was retained in the patient, and is located "somewhere between pleura and ribs." the user facility is using the silver soaker catheters for pain treatment after vat operations.Patient was sent home to follow-up with physician at a later date.
 
Manufacturer Narrative
The device history record for lot 0002988387 was reviewed and the product was produced according to product specifications.All information reasonably known as of 06 nov 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 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.
 
Event Description
Additional information received 15-oct-2020 indicated that the retained portion of the catheter was removed from the patient and measured 28cm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ON-Q EXPANSION KITS WITH SILVERSOAKER CATHETER 10 IN (25 CM), NEEDLE 8 IN. X 17
Type of Device
CATHETERS
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key10655460
MDR Text Key210911231
Report Number2026095-2020-00123
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
PMA/PMN Number
K051401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/06/2020
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 Date10/23/2021
Device Model NumberPM040-A
Device Catalogue NumberN/A
Device Lot Number0002988387
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/23/2020
Initial Date FDA Received10/09/2020
Supplement Dates Manufacturer Received10/15/2020
Supplement Dates FDA Received11/06/2020
Patient Sequence Number1
-
-