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

Model Number	UNKNOWN
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10298826
• Report Number: 3006646024-2020-00025
• Device Sequence Number: 19689810
• Product Code: MEB
• UDI-Device Identifier: 10193494430563
• UDI-Public: 10193494430563
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/12/2020
• Patient Sequence Number: 1