MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN045608
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
We had an episode of an epidural catheter shearing off upon removal on (b)(6) 2021, requiring a surgical procedure for removal.This was at vassar.The kit in use is arrow ak 05503, lot 23f21j0079.
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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 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 with no relevant findings.The customer did provide photos that appear to show a lidstock.Without the actual sample, 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
We had an episode of an epidural catheter shearing off upon removal on (b)(6) 2021, requiring a surgical procedure for removal.This was at vassar.The kit in use is arrow ak 05503, lot 23f21j0079.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• 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: 13060782
• Report Number: 1036844-2021-00184
• Device Sequence Number: 19189301
• Product Code: BSO
• UDI-Device Identifier: 70801902005143
• UDI-Public: 70801902005143
• Combination Product (Y/N): N
• 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): 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: IPN045608
• Device Catalogue Number: AK-05503
• Device Lot Number: 23F21J0079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female