MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number 381823

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/02/2024

Event Type  malfunction  

Event Description

It was reported that bd insyte autoguard package stickers are missing.The following information was provided by the initial reporter, translated from spanish to english: during the inspection, imported medical devices were found that did not have packaging stickers on their packaging.Service for the pertinent management with the supplier.

Manufacturer Narrative

A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The date received by manufacturer has been used for this field.In this mdr, bd franklin lakes, nj has been listed in sections as the manufacturing site is unknown.

Event Description

Na.

Manufacturer Narrative

A lot number was received and has been included.Correction cancel mdr: an email stating that the invima sticker is not provided by bd has been received.It is a sanitary registration# sticker is from invima, and this is not placed by the bd plant, this is a local process.As no product quality issue is reported, this does not qualify as a bd product complaint.The complaint will be closed / cancelled.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19196685
• MDR Text Key: 341795537
• Report Number: 2243072-2024-00574
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: (01)00382903818235
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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: Other
• Device Catalogue Number: 381823
• Device Lot Number: 3249700
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1