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

Model Number PM015-A

Device Problem Misconnection (1399)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.All information reasonably known as of 27-dec-2018 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).

Event Description

Fill volume: unknown, flow rate: unknown, procedure: unknown, cathplace: unknown.It was reported a misconnection occurred.The physician reported a staff member attached the on-q device to a patient intravenous (iv) line instead of the on-q soaker catheter.The clamp was closed.There was no reported patient injury.No additional information was provided.

Event Description

Additional information received (b)(6) 2018 stated the pump was a pmo15-a with 0.375% marcaine inside the device.

Manufacturer Narrative

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.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS,270 ML
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8202290
• MDR Text Key: 132383856
• Report Number: 2026095-2018-00168
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

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 Model Number: PM015-A
• Device Catalogue Number: 101371300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/27/2018
• Supplement Dates FDA Received: 01/11/2019
• Patient Sequence Number: 1
• Treatment: 0.375% MARCAINE