MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FLEXBLOCK KIT:ECHO CATH, 17GX5CM NS NDL; ANESTHESIA CONDUCTION KIT

Catalog Number FB-19605-K

Device Problems Kinked (1339); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2016

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

The anesthesiologist had difficulty threading the catheter.A catheter had a kink at the 7cm mark when it 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, stylet, and needle with no relevant findings.The customer reported the catheter was difficult to thread.The customer returned one epidural catheter with stylet and lidstock.No needle was returned.The returned catheter was visually examined with and without magnification.Visual examination of the returned catheter revealed the catheter appears used, but typical with no defects or anomalies observed.No kinks were observed on either the catheter or stylet.The outer diameter (od) of the returned catheter measured 1.06mm (caliper c05155) which is within the specification of a maximum of 1.115mm per graphic kz-19600-001; rev 1.An attempt to thread the returned epidural catheter was made.The distal end of the catheter would thread through a lab inventory 17ga needle with no resistance met.A drag test was performed per pip-013 using the returned catheter, a lab inventory other remarks: needle and weight (ga-wt-0035-008).The catheter passed the drag test with the lab inventory needle.A corrective action is not required at this time as the root cause could not be determined.The reported complaint of the catheter being difficult to thread could not be confirmed based on the sample received.The customer returned a catheter but no needle was returned.The returned epidural catheter could be thread through a 17ga lab inventory needle with no resistance met.The returned catheter passed a functional drag test, and the returned catheter od was found to be within specification.A device history record review was performed on the epidural catheter, stylet, and needle with no relevant findings.The catheter is an interactive part.Therefore, based upon the condition of the sample received and the information provided, the potential cause of this complaint could not be determined.

Event Description

The anesthesiologist had difficulty threading the catheter.A catheter had a kink at the 7cm mark when it was removed.The patient's condition was reported as fine.

• Brand Name: FLEXBLOCK KIT:ECHO CATH, 17GX5CM NS NDL
• 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: 5883647
• MDR Text Key: 52341579
• Report Number: 1036844-2016-00437
• 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: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• 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: FB-19605-K
• Device Lot Number: 23F16B0448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2016
• 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