MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CONTINUOUS PERIPHERAL NERVE BLOCK KIT; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-19608-US1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported event: the floor nurse removed the stimucath without incident and noticed that the tip of the catheter was not present.There was no visible wire component, just the polyurethane sheath.An x-ray was performed and there was no evidence of retained catheter.Upon examination, it was determined that the tip was retracted into the polyurethane sheath still intact.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer reported the distal tip retracted inside the extrusion on the catheter.The returned components were visually examined with and without magnification revealing that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned epidural catheter revealed that the catheter appears typical but used.The distal end of the catheter indicates the weld is present and intact; however, it appears most of the tip has retracted into the catheter's extrusion.No other anomalies or defects were observed.The customer also provided photos.The returned catheter was measured using a calibrated ruler.The catheter was returned in its entirety.No lot number was provided by the customer.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with a relevant finding.Other remarks: an issue with the accurate trimming of the extrusion due to bad cut which could potentially cause the extrusion to move on the spring wire guide.Further investigation has been initiated regarding this complaint issue.Based on the information provided and the results of the investigation, the potential root cause of this complaint issue is manufacturing related.The manufacturer will continue to monitor and trend related events.

• Brand Name: CONTINUOUS PERIPHERAL NERVE BLOCK 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: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 5667376
• MDR Text Key: 45574420
• Report Number: 1036844-2016-00232
• 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: 04/21/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASK-19608-US1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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