MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT: 19 GA; CATHETER, CONDUCTION, ANESTHET

Model Number	IPN056376
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
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 events.
Event or Problem Description
Today, after placing a labor epidural while trying to test dose the catheter i was absolutely unable to push the test dose through the catheter.That catheter had to be removed and again, while inspecting the catheter tip i was unable to push any fluid through the catheter.To my unaided eye there were no micro perforations at the tip of this catheter.A second kit was obtained and prior to epidural needle placement the catheter was tested and had the expected micro perforations at the tip.The defective catheter was set aside to be returned to the manufacturer.
Event or Problem Description
Today, after placing a labor epidural while trying to test dose the catheter i was absolutely unable to push the test dose through the catheter.That catheter had to be removed and again, while inspecting the catheter tip i was unable to push any fluid through the catheter.To my unaided eye there were no micro perforations at the tip of this catheter.A second kit was obtained and prior to epidural needle placement the catheter was tested and had the expected micro perforations at the tip.The defective catheter was set aside to be returned to the manufacturer.
Additional Manufacturer Narrative
Qn#(b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with a potentially relevant finding based on complaint (b)(4).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 lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed with a potentially relevant finding on the epidural catheter.However, the potential cause of this complaint could not be determined based upon the information provided and without the sample.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA
• Common Device Name: CATHETER, CONDUCTION, ANESTHET
• MDR Report Key: 12313582
• Report Number: 1036844-2021-00152
• Device Sequence Number: 3181007
• Product Code: BSO
• UDI-Device Identifier: 10801902162486
• UDI-Public: 10801902162486
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: IPN056376
• Device Catalogue Number: ASK-17019-AG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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