MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-05500-MCV1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during an epidural catheter insertion, the catheter was inserted into the wrong area and upon removal, it sheared and a tip was left inside the patient's soft tissue.The patient will be given the option to have the tip surgically removed.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit, e-17019-109a; rev.6, was reviewed as a part of this complaint investigation.The ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal.The ifu also provides alternate removal techniques if further resistance is encountered.The ifu states "stretch catheter slightly and tape it to skin, creating constant tension on the catheter." also, "injecting a small bolus of preservative-free saline while removing the catheter may be helpful." 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.Other remarks: complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the catheter with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the catheter separating could not be determined based upon the information provided and without a sample.

Event Description

It was reported that during an epidural catheter insertion, the catheter was inserted into the wrong area and upon removal, it sheared and a tip was left inside the patient's soft tissue.The patient will be given the option to have the tip surgically removed.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA
• 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: 7529815
• MDR Text Key: 108862191
• Report Number: 1036844-2018-00141
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

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 Expiration Date: 01/31/2019
• Device Catalogue Number: ASK-05500-MCV1
• Device Lot Number: 23F17K0132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 06/18/2018
• Supplement Dates FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2017
• 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