MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD¿ INSYTE AUTOGUARD BC; INTERVASCULAR CATHETER

Model Number 382533

Device Problem Packaging Problem (3007)

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

Event Date 08/20/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one unit and two photos.During the visual examination it was observed that the needle cover was not present inside of the package, the needle was bent, and the seal was not complete.Your reported defects were confirmed and are likely related to misalignment during packaging.The bent needle and incomplete seal were determined to be a result of the missing needle cover.Preventative maintenance and quality inspections are performed at regular intervals to mitigate the risk from these types of defects.A device history record review showed no non-conformances associated with this issue during the production of this batch.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 bc, the device experienced damaged or open unit package / seal where sterility of the product is compromised.The following information was provided by the initial reporter.The customer stated: this came from same day surgery when a nurse when to use the item and found it to be in a sealed package with no safety mechanism in place as well as a bent needle.I do still have the product if you would like to send a prepaid shipping label.

• Brand Name: BD¿ INSYTE AUTOGUARD BC
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 12538536
• MDR Text Key: 273546084
• Report Number: 1710034-2021-00845
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825333
• UDI-Public: 30382903825333
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 382533
• Device Catalogue Number: 382533
• Device Lot Number: 1144503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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