MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC SPINAL ANES/EPIDURAL CATH KIT: 19 GA.; ANESTHESIA CONDUCTION CATHETER

Model Number IPN923979

Device Problem Material Separation (1562)

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

Event Date 05/29/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device has not been returned for investigation.

Event Description

Epidural catheter separated from inner wire coil at the proximal end of catheter where it connects to snaplock adapter.We removed the catheter and replaced with a new catheter.The patient was unharmed but did require this second epidural catheter placement, which unfortunately took multiple attempts.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the epidural catheter and snaplock assembly with no relevant findings.Visual inspection could not be performed as no sample was returned for analysis.The customer did provide photos that appear to show an epidural catheter separation.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual 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 and snaplock assembly with no relevant findings.The customer did provide photos that appear to show an epidural catheter separation.However, 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.

Event Description

Epidural catheter separated from inner wire coil at the proximal end of catheter where it connects to snaplock adapter.We removed the catheter and replaced with a new catheter.The patient was unharmed but did require this second epidural catheter placement, which unfortunately took multiple attempts.

• Brand Name: SPINAL ANES/EPIDURAL CATH KIT: 19 GA.
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14684554
• MDR Text Key: 294394894
• Report Number: 3006425876-2022-00571
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902207750
• UDI-Public: 10801902207750
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: IPN923979
• Device Catalogue Number: ASK-05501-USC
• Device Lot Number: 23F21L0034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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
• Treatment: N/A.
• Patient Sex: Female