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

Catalog Number 381023

Device Problem Retraction Problem (1536)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

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 bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology had a needle that would not retract.The following information was provided by the initial reporter, translated from (b)(6): "after venipuncture, the hcp pressed the button to activate the safety mechanism but it was not activated and the needle was not retracted.".

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one unit and three photos.Upon inspection of the received unit and the photos it was identified that the button had been pressed but retraction had not occurred.The reported defect was confirmed.Further inspection revealed that adhesive was present at the hub and grip.The adhesive had adhered the hub and grip together preventing 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.H3 other text : see h10.

Event Description

It was reported bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology had a needle that would not retract.The following information was provided by the initial reporter, translated from japanese: "after venipuncture, the hcp pressed the button to activate the safety mechanism but it was not activated and the needle was not retracted.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
• 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: 12682737
• MDR Text Key: 278359284
• Report Number: 1710034-2021-00910
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

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: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 381023
• Device Lot Number: 0337822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2020
• 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