MAUDE Adverse Event Report: BECTON DICKINSON BD ARTERIAL CANNULA WITH FLOSWITCH

Catalog Number 682245

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

It was reported that while in the operating room a bd arterial cannula with flow switch was placed in a patient's left radial artery.Upon removal of the device it was observed that only 0.5cm of the cannula was removed and approximately 4cm of the device remained in the patient's artery.The patient received an imaging scan was performed and vascular surgeons were contacted but they were unsure if they would remove the retained cannula in surgery.A follow up appointment for the patient was made but no further information about this incident was provided.

Manufacturer Narrative

Results: one used catheter adapter assembly was returned for evaluation.A visual/microscopic analysis of the unit revealed a clean cut at the area of the break.A review of the device history record revealed no irregularities during the manufacture of the reported lot number 4346088.Conclusion: an absolute root cause for this incident cannot be determined.However, our quality engineer notes that the damage was most likely caused by a sharp object outside of the manufacturing process as there is no process within the manufacturing facility that could have caused this nonconformance.(b)(4).

• Brand Name: BD ARTERIAL CANNULA WITH FLOSWITCH
• Type of Device: ARTERIAL CANNULA
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: aaron larson ; 1 becton dr.; franklin lakes, NJ 07417 ; 8015652406
• MDR Report Key: 4895905
• MDR Text Key: 6538413
• Report Number: 2243072-2015-00120
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 682245
• Device Lot Number: 4346088
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2015
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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 Outcome(s): Required Intervention