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

Catalog Number 381854

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.

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.

Event Description

N/a.

• 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: 19195982
• MDR Text Key: 341792788
• Report Number: 2243072-2024-00571
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: UNK
• 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: 381854
• Device Lot Number: 3271689
• 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: 09/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1