MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q* PAIN RELIEF SYSTEM T-BLOC ECHOGENIC STIMULATING NEEDLE/CATHETER SET; REGIONAL ANESTHESIA

Model Number TB100ST

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

It was reported the guidewire started shearing as the anesthesiologist pulled it out and the tip was left in the patient¿s tissue but could not be located for retrieval." the user was not sure if the tip was inside of the patient."the surgeon used fluoroscopy to visualize the tip but was unsuccessful in removing the broken component.The patient appears to be fine but the tip of the guidewire is still inside the patient in the left thigh.Additional information received 10-nov-2021 stated the health care provider did not visualize the [tip] of the guidewire on fluoroscopy.When the anesthesiologist pulled the guidewire out the tip was missing so it was still inside the patient.

Manufacturer Narrative

The actual sample device was not received.However, photos were provided will be reviewed as part of the complaint investigation.A review of the device history record is in-progress.All information reasonably known as of 30-nov-2021 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.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).

Event Description

Additional information received 09-dec-2021 stated the computed tomography (ct) scan report impression notes: "extremely small 2mm metallic foreign body immediately adjacent to the left superficial femoral artery compatible with known infusion catheter fragment.The extremely tiny size and location of this foreign body makes it extremely unlikely to be of any clinical significance".

Manufacturer Narrative

The device history record for the reported lot number, 30139883, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 24-dec-2021 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.

Manufacturer Narrative

The device history record for the reported lot number, 30139883, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 23-feb-2022 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.

• 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: 12911718
• MDR Text Key: 287048806
• Report Number: 2026095-2021-00109
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00193494407926
• UDI-Public: 00193494407926
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2022

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 Expiration Date: 12/07/2022
• Device Model Number: TB100ST
• Device Catalogue Number: N/A
• Device Lot Number: 30139883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 02/02/2022; 02/02/2022
• Supplement Dates FDA Received: 12/28/2021; 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 84 KG