MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q CATHETERS-SILVERSOAKER

Model Number PM050-A

Device Problems Break (1069); Stretched (1601)

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

Event Date 03/25/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 14 apr 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 (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.Device not returned.

Event Description

Fill volume: unknown.Flow rate: unknown.Procedure: cv procedure - pneumothorax surgery.Cathplace: in between back muscles.Infusion start time: (b)(6) 2020.12:00pm.Infusion stop time: (b)(6) 2020.12:00pm.It was reported that the physician met resistance when removing the catheter.The physician kept pulling and the catheter broke; it "snapped off." patient heading for a ct [computed tomography] scan.Patient condition post incident was listed as "stable - went for ct." there was no discomfort during removal.After removal the catheter was "stretched." there was no difficulty with insertion and it was not sutured.Additional information received later in the day on 25-mar-2020 indicated that the hospital staff did not have any update on the plan for the patient.

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 03 jun 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 30-mar-2020 indicated "the team got a ct scan and did extensive ultrasound.Nothing showed up on ultrasound or ct.Afterward, the team that placed the on-q catheter did a foreign body exploration under local anesthetic at the site.They suspect the piece of the catheter thought to be left in-situ actually came out but was not found.".

• Brand Name: ON-Q CATHETERS-SILVERSOAKER
• Type of Device: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9960254
• MDR Text Key: 229286032
• Report Number: 2026095-2020-00057
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

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 Model Number: PM050-A
• Device Catalogue Number: 101354102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 03/30/2020
• Supplement Dates FDA Received: 06/03/2020
• Patient Sequence Number: 1
• Patient Age: 67 YR