MAUDE Adverse Event Report: BD BD CONNECTA WHITE 360 DEG STOPCOCK

Catalog Number 395000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fever (1858); Phlebitis (2004); Swelling (2091)

Event Type  Injury  

Event Description

The patient experienced swelling and a fever after the removal of an intravascular catheter that was used to do an (b)(4) study.A bd connecta white 360deg stopcock was used in association with the iv catheter.The patient was diagnosed with thrombophlebitis, hospitalized on (b)(6) 2014, and received medications as part of the treatment plan.Following the hospitalization and treatment, the patient was discharged to home on (b)(6) 2014.

Manufacturer Narrative

Results: at this time a sample has not been received for evaluation.It was reported that this device may coincide with either lot number 3275151, 32453000, or 3245304.A review of the device history records revealed no irregularities during the manufacture of reported lot numbers 327515, 32453000, and 3245304.Sterilization records were also reviewed for the above lot numbers and no irregularities were noted.Conclusion: without a sample, a root cause for this incident could not be identified.(b)(4).

• Brand Name: BD CONNECTA WHITE 360 DEG STOPCOCK
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: aaron larson ; one becton drive; franklin lakes, NJ 07417 ; 8015652406
• MDR Report Key: 4196838
• MDR Text Key: 4962516
• Report Number: 2243072-2014-00235
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 395000
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2014
• 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