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

Catalog Number AK-05502

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported issue: per anesthesiologist, on (b)(6) 2020, via internal email to her colleagues, she writes, issues today with tuohy needles on l & d (persons name) placed an epidural and we were unable to thread the catheter no matter what we did.Needle removed, checked - catheter would not pass through the needle.New kit opened.Procedure repeated, i had the same issue threading the catheter, but was ultimately successful.After needle removed, i check it with the catheter from the old kit, the tuohy appears to be narrow and required very precise angle to thread the catheter; even then there was resistance.Attempts made to obtain lot', and sample for inspection, however, clinician did not keep packaging, or needle in mention.

Event Description

Reported issue: per anesthesiologist on (b)(6) 2020 via internal email to her colleagues, she writes, issues today with tuohy needles on l & d (persons name) placed an epidural and we were unable to thread the catheter no matter what we did.Needle removed, checked - catheter would not pass through the needle.New kit opened; procedure repeated - i had the same issue threading the catheter but was ultimately successful.After needle removed, i check it with the catheter from the old kit, the tuohy appears to be narrow and required very precise angle to thread the catheter; even then there was resistance.Attempts made to obtain lot' and sample for inspection, however, clinician did not keep packaging or needle in mention.

Manufacturer Narrative

Qn# (b)(4).A lot number was not provided.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 review of design change history for kit ak-05502, part number nz-05500-001, and kz-05400-002 was performed as a part of this investigation.No design changes have been made to this product in the past two years that would 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.A device history record review was performed on the epidural catheter and needle with no relevant findings.The potential cause of catheter not advancing could not be determined based upon the information provided and without a sample.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10719480
• MDR Text Key: 212594090
• Report Number: 1036844-2020-00261
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

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 Catalogue Number: AK-05502
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1