MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD INSYTE AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number 382523

Device Problems Bent (1059); Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2017

Event Type  malfunction  

Event Description

Rn opened iv insyte cannula package and noted insyte cannula was pulled away from needle and bent upon opening the package.No patient contact with product.Manufacturer response for iv catheter kit, bd insyte autogruard bc (per site reporter): equipment failure called to beckon dickinson company customer service at (b)(6).Arrangements made by medline inc.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 9450 s state street; sandy UT 84070
• MDR Report Key: 6830597
• MDR Text Key: 83984011
• Report Number: 6830597
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2017,08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 382523
• Device Lot Number: 6357802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1