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

Catalog Number 381023

Device Problem Retraction Problem (1536)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one used unit and six photos.Upon inspection of the received unit and the photos, it was identified that the button had been pressed but retraction did not occur.The reported defect was confirmed.Further inspection revealed that adhesive was present on the exterior of the needle hub.Retraction was attempted but resistance was encountered.Upon applying excess force, the corner of the button cracked and then the needle retracted.Inspection of the separated components found that adhesive was present between the button and needle hub which had prevented retraction from occurring.During manufacturing, adhesive may be incorrectly placed due to adhesive build up or part misalignment.Preventative maintenance and in process sampling are performed at regular intervals to mitigate the risk from this type of 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.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.Investigation conclusion: reported defect of needle retraction failure was confirmed.Root cause was determined to be manufacturing related.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter experienced a needle that would not retract.The following information was provided by the initial reporter: according to the customer's report, the hcp pressed the button to retract the needle; however, the needle was not retracted.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 12724529
• MDR Text Key: 280110231
• Report Number: 1710034-2021-00929
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 381023
• Device Lot Number: 1025765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2021
• 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