MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEM BD INSYTE; CATHETER

Lot Number 8037528

Device Problem Device Packaging Compromised (2916)

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

Event Date 06/13/2018

Event Type  malfunction  

Event Description

Iv catheter was visually inspected upon removal from package.Catheter was found to have a piece of plastic sticking out sideways on the sheath.Catheter was given to the nurse manager.Catheter did not reach the patient.

• Brand Name: BD INSYTE
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEM; sandy UT 84070
• MDR Report Key: 7628892
• MDR Text Key: 112190342
• Report Number: MW5078001
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Lot Number: 8037528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1