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

Catalog Number MP-17019-TKL

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

While attempting to remove the epidural catheter it separated towards the distal end and the wire unraveled.Patient had a ct scan, did not find any metal in the patient's body and could not visualize any catheter fragments.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).Visual inspection could not be performed as no sample was returned for analysis.However, the customer did submit a photo.The submitted photo shows a damaged catheter that looks to have separated (reference files (b)(4)).The ifu for this kit, (b)(4), 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.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." a corrective action is not required at this time.Although, the customer submitted a photo, a 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.Although, the customer submitted of photo that show a separated catheter, the potential cause of the catheter being difficult to remove could not be determined based upon the information provided and without a sample.

Event Description

While attempting to remove the epidural catheter it separated towards the distal end and the wire unraveled.Patient had a ct scan, did not find any metal in the patient's body and could not visualize any catheter fragments.The patient's condition was reported as fine.

• 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 carringtin mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5856940
• MDR Text Key: 51481538
• Report Number: 1036844-2016-00424
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: MP-17019-TKL
• Device Lot Number: 23F16C0995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2016
• 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
• Patient Outcome(s): Required Intervention