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

Model Number TBT02100T

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.The device history record for the reported lot number, 0203243788, 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 (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 Description

It was reported the catheter was inserted in the patient but shredded.The physician used another catheter to compare the length to see if everything was removed, but the tip was missing on the removed catheter.The patient was reported to be "ok" at the time of the incident.The patient was undergoing a pain procedure.

Manufacturer Narrative

One sample device was returned with an original pouch packaging.The device was evaluated and the catheter was confirmed to have consistent breaks and the black portion at the tip was not present.The peripheral catheter instructions for use (ifu) advise the following in order to prevent catheter shearing: not withdrawing, tugging, or quickly pulling on the catheter during removal from patient.The cause of the damage observed appeared to be procedural.A damaged catheter would have been noticeable by the physician before the procedure.The root cause was inappropriate use.All information reasonably known as of 08-apr-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, 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.

• Brand Name: ON-Q PAIN RELIEF SYSTEM T-BLOC CONTINUOUS ECHOGENIC NERVE BLOCK TRAY
• Type of Device: REGIONAL ANESTHESIA
• MDR Report Key: 9799266
• MDR Text Key: 190760133
• Report Number: 3006646024-2020-00005
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 10680651407846
• UDI-Public: 10680651407846
• Combination Product (y/n): N
• PMA/PMN Number: K073187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: TBT02100T
• Device Catalogue Number: 104078401
• Device Lot Number: 0203243788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR