MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Model Number 381834

Device Problem Illegible Information (4050)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd insyte¿ autoguard¿ shielded iv catheter the label or package was smeared/print permanency (illegible).This event occurred 100 times.The following information was provided by the initial reporter.The customer stated: there was "poor printing of the product packaging.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for evaluation? yes? d10: returned to manufacturer on: 2021-07-16.H6: investigation summary our quality engineer inspected the devices submitted for evaluation.Bd received 50 sealed packages which were lacking printed product information.The issue was confirmed.Preventative maintenance logs were reviewed, which verified all printing equipment and vision detection systems were up to date and functioning properly.The missing print most likely occurred as a result of human error during the manual inspection process.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported when using the bd insyte¿ autoguard¿ shielded iv catheter the label or package was smeared/print permanency (illegible).This event occurred 100 times.The following information was provided by the initial reporter.The customer stated: there was "poor printing of the product packaging.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12214981
• MDR Text Key: 263371137
• Report Number: 1710034-2021-00605
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

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 Expiration Date: 11/30/2023
• Device Model Number: 381834
• Device Catalogue Number: 381834
• Device Lot Number: 0342877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/22/2021
• Supplement Dates Manufacturer Received: 08/29/2021
• Supplement Dates FDA Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1