MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SETS; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN040178
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related even.
Event or Problem Description
We had a second catheter that was not patent.No holes.That is obviously not ideal and relates to potential patient complications when the patient requires a second placement procedure.
Event or Problem Description
We had a second catheter that was not patent.No holes.That is obviously not ideal and relates to potential patient complications when the patient requires a second placement procedure.
Additional Manufacturer Narrative
Qn#(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION SETS
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• MDR Report Key: 12210197
• Report Number: 1036844-2021-00143
• Device Sequence Number: 11943325
• Product Code: BSO
• UDI-Device Identifier: 20801902070177
• UDI-Public: 20801902070177
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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 Expiration Date: 06/30/2022
• Device Model Number: IPN040178
• Device Catalogue Number: MP-17019-TIG
• Device Lot Number: 13F20F0251
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1