MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ ARTERIAL CANNULA WITH BD FLOSWITCH¿ 1-WAY STOPCOCK; WIRE GUIDE CATHETER

Catalog Number 682245

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation results: one representative sample from batch 7075490 was returned for investigation.There is a 100% leak test inspection station at the assembly machine to ensure the flow of the catheter is blocked when the flow switch is activated.The sample was challenged at the inspection station and passed the inspection.The sample was then subjected to measure the flow switch button activation force.A review of the device history record of packaged needle 682245 revealed no irregularities during the manufacture of the reported lot # 7075490 the result showed that the flow switch button activation force was within specification.Thus, the nonconformance cannot be confirmed.Investigation conclusion: the sample had passed the leak test inspection and the flow switch button activation force was within specification.Root cause description: no root cause was established as the sample had passed the leak test inspection and the flow switch button activation force was within specification.

Event Description

It was reported that the flow switch on a bd¿ arterial cannula with bd floswitch ¿ 1-way stopcock did not work during use causing the patient¿s blood to spill on the physician¿s clothing.There was no report of exposure, injury or medical intervention.

• Brand Name: BD¿ ARTERIAL CANNULA WITH BD FLOSWITCH¿ 1-WAY STOPCOCK
• Type of Device: WIRE GUIDE CATHETER
• 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: 7261638
• MDR Text Key: 100001830
• Report Number: 8041187-2018-00020
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K925947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 682245
• Device Lot Number: 7075490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2017
• 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