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

Catalog Number 682245

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2017

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 a bd¿ arterial cannula with bd flowswitch¿ failed to contain blood properly.No injury or medical intervention.

Manufacturer Narrative

Investigation summary: one representative sample in sealed package and one used sample in opened package were returned for investigation.Both the returned samples were subjected to flow button switch activation test.Flow button switch activation test is used to evaluate the force required to lock and unlock the flow switch.From the test results, both the samples met the product specification.Dhr review: device history record was reviewed no quality notification was raised for similar nonconformance during the production of this batch.Investigation conclusion: flow switch button activation test for both returned samples met the product specification.Bd was not able to duplicate or confirm the customer¿s indicated failure mode.Root cause description: the root cause was not able to be determined as the flow switch button activation test for both the returned samples met the product specification.

Manufacturer Narrative

Correction: date received by manufacturer: 11/27/2017.

• 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: 7079551
• MDR Text Key: 94200253
• Report Number: 8041187-2017-00244
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 682245
• Device Lot Number: 7110140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2017
• 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