MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE INTRAVASCULAR CATHETER 22 G X 1"

Catalog Number 388312

Device Problem Component Missing (2306)

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

Event Type  Injury  

Event Description

It was reported that while removing a bd insyte iv catheter from a patient, a piece of the catheter was found to be missing.The patient received an x-ray which did not show the catheter.

Manufacturer Narrative

Photographs of the affected unit were provided for evaluation.Review of the returned photos confirmed the catheter had broken.A review of the device history records revealed no irregularities during the manufacture of reported lot number 3331062.No issues affecting the radiopacity of the device in question were observed during this review.Conclusions: based on the provided photos, it is concluded that the catheter may have come into contact with some sort of sharp object or instrument during use, resulting in the break.

• Brand Name: BD INSYTE INTRAVASCULAR CATHETER 22 G X 1"
• Type of Device: INTRAVASCULAR CATHETER
• 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: 4320369
• MDR Text Key: 5210412
• Report Number: 2243072-2014-00283
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 11/25/2014

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: Other
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 388312
• Device Lot Number: 3331062
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/10/2014
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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