MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER

Catalog Number 381023

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

Results: bd received one sample unit for evaluation by our quality engineer team. Upon examination, the needle was observed to be partially retracted and damage was found on the grip and at the connection of the grip and the barrel. The needle was repositioned and the button was pressed, the needle retracted unsuccessfully. The defect was determined to have occurred during the manufacturing process. During production, the plug probe and load barrel stations have the ability to become misaligned and produce the type of damage observed. Proper personnel have been notified. A review of the device history record could not be performed as the lot number was not provided. The samples were visually and microscopically evaluated and the customer's indicated failure mode for safety mechanism failure during use was observed. Functional testing was performed. It was observed that when the needle was pushed and repositioned to the out position. The button was depressed and the retraction was unsuccessful. Conclusions: the defect needle retraction failure, as stated in the description of the complaint, was confirmed with the returned unit. The returned unit displayed damage to the grip component. Conclusion: root cause relationship of device to the reported incident: manufacturing. Comment: the plug probe and the load barrel stations in zone 5 have the ability to become misaligned and produce the type of damage observed in the returned sample. When there is a misalignment, the probe inadvertently contacts the edge of the grip and causes the damage observed in the complaint.

Manufacturer Narrative

Medical device expiration date: unknown. No lot # provided. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.

Event Description

It was reported that during use, a bd insyte¿ autoguard¿ bc shielded iv catheter safety mechanism failed to activate. There was no report of injury or medical intervention reported.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7170138
• MDR Text Key: 266587234
• Report Number: 1710034-2017-00508
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381023
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/05/2018 Patient Sequence Number: 1