MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SETS; ANESTHESIA CONDUCT KIT

Model Number	IPN040048
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Epidural catheterization kit broke mid procedure.Customer was doing a caudal epidural and in the last part of the procedure the customer noticed a failure in the wall of the catheter specifically.The contrast showed ballooning of the wall.The customer was able to retrieve the catheter with no adverse outcome to the patient that they are aware of.On further inspection of the catheter post-procedure they noticed a longitudinal tear in the wall of the catheter.Due to severity of the issue, the customer is requesting immediate follow-up.
Event or Problem Description
Epidural catheterization kit broke mid procedure.Customer was doing a caudal epidural and in the last part of the procedure the customer noticed a failure in the wall of the catheter specifically.The contrast showed ballooning of the wall.The customer was able to retrieve the catheter with no adverse outcome to the patient that they are aware of.On further inspection of the catheter post-procedure they noticed a longitudinal tear in the wall of the catheter.Due to severity of the issue, the customer is requesting immediate follow-up.
Additional Manufacturer Narrative
(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.The customer did provide a photo that appears to show an epidural catheter tip.However, without the actual sample, the potential cause of this complaint could not be determined based upon the information provided.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION SETS
• Common Device Name: ANESTHESIA CONDUCT KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12967573
• Report Number: 1036844-2021-00179
• Device Sequence Number: 14498082
• Product Code: CAZ
• UDI-Device Identifier: 10801902005097
• UDI-Public: 10801902005097
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K801912
• 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): 12/08/2021

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: 05/31/2023
• Device Model Number: IPN040048
• Device Catalogue Number: AK-05000
• Device Lot Number: 13F21F0508
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown