MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. SPINAL ANES/EPIDURAL CATH KIT; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-05560-OM1

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation report has not been submitted at this time.The manufacturer will continue to monitor and trend related events.

Event Description

Anesthesia noticed at first that it was hard to push medication through the end of the catheter.When the epidural was discontinued the wire was protruding through the end of the catheter.The entire device was removed.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter coil wire was protruding at the distal tip when the catheter was being removed from the patient.The customer returned one snaplock adapter, one epidural catheter and one non-teleflex syringe for investigation.The components were received connected together (reference attached files (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 catheter appears used.The distal end shows signs of stretching and coil wire appears to be stretched and the extrusion is damaged, but the distal tip is intact.The coil wire is stretched beyond the catheter extrusion tip.The proximal side of the catheter appears to be intact as no damage was observed.No other defects or anomalies were observed (reference (b)(4)).A dimensional inspection was performed on the returned catheter using a ruler ((b)(6)).The returned catheter extrusion measures approximately other remarks: 120cm.The inner coils are stretched and extend approximately 1.5cm beyond the tip of the extrusion.The extrusion appears to be stretched at the distal end of the catheter.This is why the catheter is well beyond outside of the specification of 88.5-91.5 cm per graphic (b)(4).No part of the catheter appears to be missing.Specifications per graphic (b)(4) were reviewed as a part of this complaint investigation.The ifu for this product, (b)(4), was also reviewed as a part of this complaint investigation.The ifu contains catheter removal instructions with a list of warnings including, "never tug or quickly pull on catheter during removal from patient to reduce risk of breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.During epidural catheter removal, the literature indicates a force of approximately 1/3 of a pound is all that is necessary to exert if patient is properly positioned in the recommended lateral neutral position." the ifu also provides alternate catheter removal techniques if difficulty is encountered and indicates "since any epidural catheter can inadvertently be separated if excessive force is applied during removal , clinicians must be aware of the importance of proper removal technique." a corrective action is not required at this time as the condition of the sample received indicates operational context caused or contributed to this event.The reported complaint of the coil wire protruding at the tip was confirmed based upon the sample received.The distal end of the returned catheter was intact, however, there were signs of stretching and the coil wire was stretched beyond the extrusion.The ifu for this product warns the user not to apply additional tension if the catheter begins to stretch as there is a risk for separation.Therefore , based upon the condition of the sample received and the observed evidence of stretching at the distal end, operational context caused or contributed to this event.

Event Description

Anesthesia noticed at first that it was hard to push medication through the end of the catheter.When the epidural was discontinued the wire was protruding through the end of the catheter.The entire device was removed.The patient's condition was reported as fine.

• Brand Name: SPINAL ANES/EPIDURAL CATH KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• 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: 6152491
• MDR Text Key: 61716866
• Report Number: 1036844-2016-00625
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: ASK-05560-OM1
• Device Lot Number: 23F16J0531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1