MAUDE Adverse Event Report: ARROW INTERNATIONAL INC ARROW FLEXBLOCK SET: ECHO CATH, 17G X 9CM NS NDL; ANESTHESIA CONDUCTION KIT

Catalog Number FB-19609-SNS

Device Problem Stretched (1601)

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

Event Date 12/15/2014

Event Type  malfunction  

Event Description

The customer alleges that the re-enforcing internal wire was noted to have pulled out of the catheter tip during withdraw of the device.X-rays did not show any evidence of retained foreign body.No patient injury reported.

Manufacturer Narrative

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

• Brand Name: ARROW FLEXBLOCK SET: ECHO CATH, 17G X 9CM NS NDL
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL C.R. A.S.; jamska 235947; zdar nad sazavou 591 01; EZ 591 01
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4402121
• MDR Text Key: 5126962
• Report Number: 3006425876-2015-00006
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: FB-19609-SNS
• Device Lot Number: 71F14A1432
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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
• Patient Age: 67 YR