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

Catalog Number AK-05503-L

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the epidural catheter was placed by the anesthesiologist and would not work properly, the catheter was then rem oved, and upon removal it was noted that the catheter tip was not patent.There was no patient injury.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter tip was not patent.According to an internal note for this complaint, the customer refers to "patent" as open.The customer returned one 20ml luer-slip syringe, one snaplock adapter, and one epidural catheter for investigation.The components were received connected together (reference attached (b)(4)).The returned sample was visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears used as biological material can be seen on the inner coils.Microscopic examination of the returned catheter revealed the likely most proximal end appears to be missing.The coils extend beyond the extrusion and it appears the catheter's extrusion does not have a clean cut as compared to a lab inventory catheter (reference attached files (b)(4)).No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter using a ruler (c05158).The returned catheter extrusion measures approximately 86.8cm.At least 1.7cm of the catheter is missing as the specification for the epidural catheter indicates that the proper length of an epidural catheter is 88.5-91.5 cm per graphic kz-05400-002 rev.9.A functional flow test was performed on the returned sample per mrq 000017 section 7.8; rev.7.The returned epidural catheter was inserted from the proximal end into the returned snaplock adapter until it bottomed out and the snaplock adapter was closed.The components were confirmed to be secured by tugging gently.The snaplock adapter was connected to the lab leak tester (c05176) and the pressure was increased to 10 psi to establish flow.Water could be seen immediately exiting the distal end of the catheter.Specifications per graphic kz-05400-002 rev.9 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-109a; rev.6, was reviewed as a part of this complaint investigation.The ifu cautions the user "do not alter the catheter or any other kit/set component during insertion, use or removal (except as instructed)." a corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.Although, the reported complaint of the catheter's tip not being "patent", meaning not open, could not be confirmed, the catheter was received with the likely most proximal end missing.Therefore, based on the condition of the sample received and the time of discovery indicate operational context caused or contributed to this event.The reported complaint of the catheter's tip "not patent" could not be confirmed based on the sample received.According to an internal note, the customer refers to "patent" as open.The returned sample passed a functional flow test; however, the catheter was received with the proximal tip missing.The ifu for this product indicates not to alter the catheter or any other kit/set component during insertion, use or removal (except as instructed).A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, based upon the condition of the sample received, operational context caused or contributed to this event.

Event Description

It was reported that the epidural catheter was placed by the anesthesiologist and would not work properly, the catheter was then removed, and upon removal it was noted that the catheter tip was not patent.There was no patient injury.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7369917
• MDR Text Key: 103527707
• Report Number: 1036844-2018-00093
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: AK-05503-L
• Device Lot Number: 23F17L0454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1