MAUDE Adverse Event Report: ARROW INTL., INC. ARROR EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Catalog Number CA-02220

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2014

Event Type  malfunction  

Event Description

Complaint alleges that the tip of the needle was bent during use.There was no report of pt injury.

Manufacturer Narrative

No lot number was provided by the customer, however, a device history record (dhr) review was performed on lot number 23f13g0444, based on sales history and there were no relevant findings.Complaint verification testing could not be performed as no sample was returned for analysis.The device history records for the epidural needle were reviewed with no evidence to suggest a manufacturing related cause, therefore, the complaint could not be confirmed and a root cause could not be established.

• Brand Name: ARROR EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; p.o. box 12600; rtp, NC 07709 ; 9194334854
• MDR Report Key: 3972836
• MDR Text Key: 4748457
• Report Number: 1036844-2014-00168
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CA-02220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2014
• 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