MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q TUNNELERS & SHEATHS, DISPOSABLE, 8 IN. / 17 GA; INTRODUCERS

Model Number	T17X8
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 device is reported to be available but has not been returned for evaluation; however, a photograph of the device was provided a review of the device history record is not possible as no lot number was provided.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
It was reported while the physician was placing a catheter via a tunneler/introducer for an intercostal nerve block.After tunneling the catheter, the physician snapped the top of the t-peel sheath and began to remove it.The t-peel broke leaving the majority of the broken device inside of the patient.The surgeon took the patient back to the operating room or and removed the remaining sheath.There was no reported injury.
Additional Manufacturer Narrative
The sample was received in two pieces and reviewed for evaluation.During inspection the t-peel sheath showed the lines on both sides were torn and separated.A root cause related with the manufacturing process was not found; therefore, the root cause wa deemed to be unknown.All information reasonably known as of (b)(6) 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 (b)(4), 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 TUNNELERS & SHEATHS, DISPOSABLE, 8 IN. / 17 GA
• Common Device Name: INTRODUCERS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12163306
• Report Number: 2026095-2021-00073
• Device Sequence Number: 4052830
• Product Code: BSO
• UDI-Device Identifier: 00193494137397
• UDI-Public: 00193494137397
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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: T17X8
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1