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

Catalog Number AK-05502

Device Problems Plunge (1462); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual, functional and dimensional inspection could not be performed as no sample was returned for analysis.No lot number was provided.A device history record review was performed based on lot number 23f15d0277 from sales history.A device history record review was performed on the lor syringe with no relevant findings.A corrective action is not required at this time as a potential cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.The potential cause of lor syringe plunger sticking in the barrel could not be determined based upon the information provided and without a sample.

Event Description

The customer alleges that the barrel/plunger would stick in the syringe giving poor feeling during a procedure.No patient injury reported.

• Brand Name: ARROW EPIDURAL CATHETERIZATION 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: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5191206
• MDR Text Key: 30368171
• Report Number: 1036844-2015-00487
• 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: Other
• Type of Report: Initial
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AK-05502
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1