MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN CATHETER; CATHETERS

Model Number UNKNOWN

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product is not available for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 14 jul 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 complaint database and identified as complaint (b)(4).Device not returned.

Event Description

It was reported the patient's right sided rectus sheath became stuck.Removal of the catheter was attempted by the team consultant doctor.The catheter was removed, but was missing the blue tip.The patient was instructed to have an mri (magnetic resonance imaging) or ct (computed tomography) scan as an outpatient to confirm the position of the tip, and, if removal is necessary, then it will be removed under local anesthetic.

Manufacturer Narrative

Correction: a udi was included in the initial report in error, as the exact product information was not provided by the customer.This has been corrected in d4 to unknown.All information reasonably known as of (b)(6)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: UNKNOWN CATHETER
• Type of Device: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10298826
• MDR Text Key: 213418139
• Report Number: 3006646024-2020-00025
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 10193494430563
• UDI-Public: 10193494430563
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2020
• Patient Sequence Number: 1