MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿

Catalog Number 682245

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use a bd¿ arterial cannula with bd flowswitch¿ was found with a difficult floswitch slide valve.This malfunction could lead to possible leakage.There was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: one unused actual sample in open package was returned for investigation.Our quality engineer inspected the returned unit and could not identify any manufacturing related defects.The sample was subjected to the flow switch button operation test which this test evaluates the force required to ¿on¿ and ¿off¿ the flow switch button.The test results had met flow switch button operation specifications.A device history record review showed no non-conformances associated with this issue during the production of this batch.Investigation summary: unconfirmed: device met operational specifications.Root cause could not be determined.

• Brand Name: BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿
• Type of Device: ARTERIAL CANNULA
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7355795
• MDR Text Key: 103086530
• Report Number: 8041187-2018-00082
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 682245
• Device Lot Number: 7199170
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• 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 Outcome(s): Other