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

Model Number	IPN923979
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.
Event or Problem 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.
Additional 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 or Problem 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.
• Common Device Name: 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
• Report Number: 3006425876-2022-00571
• Device Sequence Number: 4818287
• Product Code: BSO
• UDI-Device Identifier: 10801902207750
• UDI-Public: 10801902207750
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/31/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Female