MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT: 19 GA; ANESTHESIA CONDUCTION CATHETER

Model Number IPN045606

Device Problem Complete Blockage (1094)

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

Event Date 03/16/2022

Event Type  malfunction  

Event Description

Ran into this issue today on l & d.Epidural catheter was sealed at the proximal end.Additional information: the catheter had already been inserted into the patient.Because the defect was the end distal to the patient it was not discovered until the tuochy needle was removed and something caught as the catheter passed through the lumen.I ended up taking sterile scissors and cutting off the sealed portion which allowed the catheter to function as normal.

Manufacturer Narrative

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

Event Description

Ran into this issue today on l & d.Epidural catheter was sealed at the proximal end.Additional information: the catheter had already been inserted into the patient.Because the defect was the end distal to the patient it was not discovered until the tuochy needle was removed and something caught as the catheter passed through the lumen.I ended up taking sterile scissors and cutting off the sealed portion which allowed the catheter to function as normal.

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.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 KIT: 19 GA
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• 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: 13839474
• MDR Text Key: 287537977
• Report Number: 1036844-2022-00019
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 40801902005128
• UDI-Public: 40801902005128
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: IPN045606
• Device Catalogue Number: AK-05501
• Device Lot Number: 23F21J0082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 05/02/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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
• Treatment: N/A.