MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381934

Device Problem Material Deformation (2976)

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

Event Date 08/17/2021

Event Type  malfunction  

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter hub was defective and partially separated from the catheter.The following information was provided by the initial reporter, translated from (b)(6) to english: "one autogard 20g catheter kinked in its packaging and not used." via bd investigation: "upon inspection of the received unit, it was identified that neither the catheter or needle were bent but the hub was bent inside the grip.The defect of component damage was confirmed.The hub was then removed from the grip and barrel assembly for further inspection revealing that the hub had been bent resulting in it partially separating causing the catheter to appear bent.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Date received by manufacturer: bd was initially made aware of this complaint on (b)(6) 2021.At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.Additional information was later received on 2021-10-27 that changed the reportability determination.Based on the additional information received, this complaint is now considered to be an mdr reportable incident.Investigation summary: our quality engineer inspected the sample submitted for evaluation.Upon inspection of the received unit, it was identified that neither the catheter or needle were bent but the hub was bent inside the grip.The defect of component damage was confirmed.The hub was then removed from the grip and barrel assembly for further inspection revealing that the hub had been bent resulting in it partially separating causing the catheter to appear bent.The defect was determined to have occurred during the manufacturing/ packaging process, most likely having occurred prior the sealing of the package and after the catheter was placed.Operators perform function testing and visual inspections for damage or bent needles throughout the manufacturing process to mitigate the risk from this type defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.The appropriate personnel have been notified and we appreciate you taking the time to bring this observation to our attention.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.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12802624
• MDR Text Key: 280948539
• Report Number: 1710034-2021-00982
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 381934
• Device Lot Number: 1082943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• 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