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

Model Number	IPN919609
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
We have definitely seen an increase in procedures where we have difficulty threading.This is more often than before.When we would occasionally see some difficulty getting the catheter too past the needle tip.In many recent cases the catheter appears to get hung up at the tip, but instead of being able to finesse it through we often see the catheter kink badly within the tuohy hub, essentially so that it bunches up instead of threads forward.In my experiences, once we see that bunching in the tuohy hub it is impossible to advance that catheter because bunching up is all it will do from then on.Switching catheters often seem to fix the problem.This has led many of us to believe that the current batch of arrow catheters are softer or have a greater propensity to kink and fold rather than thread forward.Some of our anesthesiologists have moved away from using arrow kits for this reason.There has been discussion of taking the issue to the safety board due to having an open port and needing to replace the catheter with a new catheter during the procedure.No product was obtained at this time because the account claims this happens occasionally and did not hold product.I have directed them to report each incidence and hold the product and alert me immediately moving forward.
Event or Problem Description
We have definitely seen an increase in procedures where we have difficulty threading.This is more often than before when we would o occasionally see some difficulty getting the catheter too past the needle tip.In many recent cases the catheter appears to get hung up at the tip, but instead of being able to finesse it through we often see the catheter kink badly within the tuohy hub, essentially so that it bunches up instead of threads forward.In my experiences, once we see that bunching in the tuohy hub it is impossible to advance that catheter because bunching up is all it will do from then on.Switching catheters often seem to fix the problem.This has led many of us to believe that the current batch of arrow catheters are softer or have a greater propensity to kink and fold rather than thread forward.Some of our anesthesiologists have moved away from using arrow kits for this reason.There has been discussion of taking the issue to the safety board due to having an open port and needing to replace the catheter with a new catheter during the procedure.No product was obtained at this time because the account claims this happens occasionally and did not hold product.I have directed them to report each incidence and hold the product and alert me immediately moving forward.
Additional Manufacturer Narrative
(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 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.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.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 KIT
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• 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: 13499817
• Report Number: 1036844-2022-00008
• Device Sequence Number: 4034138
• Product Code: BSO
• UDI-Device Identifier: 10801902189117
• UDI-Public: 10801902189117
• 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): 01/27/2022

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 Model Number: IPN919609
• Device Catalogue Number: AK-05502
• Device Lot Number: UNKNOWN
• 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: 01/27/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/17/2022
• 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