MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q T-BLOC CONTINUOUS TRAY WITH NEEDLE; REGIONAL ANESTHESIA

Model Number TBT02100ST

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 15 mar 2022 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).

Event Description

Avanos medical inc.Received a single report that referenced two different incidences, which were associated with two separate patients.This is the second of two reports.Refer to 2026095-2022-00013 for the first report.It was reported there was an incident of possible catheter shearing upon removal.There was no report of medical intervention.The date of surgery (b)(6) 2021.Additional information received 08mar2022 reported that at some point catheter a removal was attempted and approximately 4 centimeters of the catheter was left inside the patient.There was no reported injury.

Manufacturer Narrative

Root cause could not be determined.The device history record for lot 30163419 was reviewed and the product was produced according to product specifications.All information reasonably known as of 07 may2022 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: ON-Q T-BLOC CONTINUOUS TRAY WITH NEEDLE
• Type of Device: REGIONAL ANESTHESIA
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 13777209
• MDR Text Key: 289687784
• Report Number: 2026095-2022-00014
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00193494407780
• UDI-Public: 00193494407780
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2023
• Device Model Number: TBT02100ST
• Device Catalogue Number: N/A
• Device Lot Number: 30163419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 68 KG