MAUDE Adverse Event Report: ON-Q PAIN RELIEF SYSTEM T-BLOC CONTINUOUS ECHOGENIC STIMULATING NERVE BLOCK TRY; REGIONAL ANESTHESIA

Model Number	TBT02100ST
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.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.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 or Problem Description
Procedure: total knee procedure.Cathplace: adductor canal.It was reported, "anesthesia placed a femoral adductor canal block for a total knee procedure.At the designated time to remove, the post-op nurse was unable to pull the catheter out.One of anesthesia providers attempted to remove.It was difficult and then the catheter broke.An x-ray revealed that some portion of the catheter remained.The provider consulted with [the] (anesthesia -pain) physician.The patient was taken to a procedure room where the remainder of the catheter was removed under fluoroscopic guidance." the catheter tip appeared intact when it was removed.The patient tolerated the removal procedure "well" and no complications were encountered.

• Brand Name: ON-Q PAIN RELIEF SYSTEM T-BLOC CONTINUOUS ECHOGENIC STIMULATING NERVE BLOCK TRY
• Common Device Name: REGIONAL ANESTHESIA
• MDR Report Key: 9970197
• Report Number: 3006646024-2020-00012
• Device Sequence Number: 11681525
• Product Code: CAZ
• UDI-Device Identifier: 10680651407785
• UDI-Public: 10680651407785
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K073187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2020

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: TBT02100ST
• Device Catalogue Number: 104077803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/16/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 58