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

Model Number	IPN045607
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The inability to thread a catheter through a broken tuohy needle.Additional information: the catheter could not advance through the needle.I do not know if the needle actually broke.
Event or Problem Description
The inability to thread a catheter through a broken tuohy needle.Additional information: the catheter could not advance through the needle.I do not know if the needle actually broke.
Additional Manufacturer Narrative
Qn #(b)(4).The lot number provided was for kit ak-05560.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter and needle with no relevant findings.A design history review was performed for part # kz-05500-007 and kz-005400-002 as a part of this complaint investigation.There have been no material changes for these parts during the last two years that could have led to this complaint.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.The lot number provided was for a different kit number.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter and needle with no relevant findings.The potential cause of this complaint could not be determined based upon the information provided and without the sample.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION KI
• 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: 12635735
• Report Number: 1036844-2021-00165
• Device Sequence Number: 3413713
• Product Code: BSO
• UDI-Device Identifier: 60801902005139
• UDI-Public: 60801902005139
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/30/2021

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 Model Number: IPN045607
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F21D0233
• 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: 09/30/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Female