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

Model Number IPN040048

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 281987099
• Report Number: 1036844-2021-00179
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 10801902005097
• UDI-Public: 10801902005097
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K801912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1