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

Catalog Number WJ-05401

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleges that the plunger is sticking which is preventing loss of resistance.No patient injury reported.

Manufacturer Narrative

(b)(4).The customer returned one glass lor syringe and a lidstock from lot 23f14g1260 for investigation.A visual exam was performed and it was observed that the syringe barrel was broken into several pieces.All pieces appear to have been returned.The syringe plunger appeared typical with no observed defects.Functional inspection could not be performed using the returned syringe barrel; however, a functional plunger movement test could be performed using the returned syringe plunger and a lab inventory syringe barrel of the same type.No functional issues were found.A device history record (dhr) review was performed on the lor syringe with no relevant findings.The reported complaint of the syringe plunger sticking could not be confirmed based upon the sample received.The syringe barrel was received shattered.It is unknown at what point the syringe barrel was damaged.A dhr review was performed on the lor syringe with no evidence to suggest a manufacturing related cause.The potential cause of the syringe plunger sticking could not be determined as functional testing could not be performed on the syringe barrel based upon the condition it was received.

Event Description

The customer alleges that the plunger is sticking which is preventing loss of resistance.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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5169129
• MDR Text Key: 28985166
• Report Number: 1036844-2015-00492
• 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: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WJ-05401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2015
• 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: Initial
• Patient Sequence Number: 1