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

Model Number PM025-A

Device Problem Break (1069)

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.Root cause could not be determined.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.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 (b)(4).

Event Description

Fill volume: unknown.Flow rate: unknown.Procedure: breast augmentation.Cathplace: right breast.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the catheter "possibly broke when the nurse removed the drain and cut the stitch holding the drain and the catheter down.They could not locate it [the catheter] via x ray today but was looking for other options." surgeon unknown if this was cut by the nurse who removed the catheter or not.Additional information received 03-jul-2019 indicated the "patient's friend who is a nursing student removed the catheter by accidentally cutting it and that is why it was retained.Catheter was located via ultrasound and removed on (b)(6) [(b)(6)2019] without incident.".

• Brand Name: ON-Q FIXED FLOW PUMP KITS WITH ON-Q SILVERSOAKER CATHETER
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 8815522
• MDR Text Key: 151863469
• Report Number: 2026095-2019-00139
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM025-A
• Device Catalogue Number: 101371803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1