MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER

Model Number	382537
Medical Device Problem Codes	Fluid/Blood Leak (1250); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter with blood control technology needle got "stuck" on the valve and would not retract, leaking out blood as a result.The following information was provided by the initial reporter: "has it been reported to you that the us iv will not retract?? it gets stuck on valve and when we can get it loose, then there is blood everywhere.We have had this happen several times.".
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter with blood control technology needle got "stuck" on the valve and would not retract, leaking out blood as a result.The following information was provided by the initial reporter: "has it been reported to you that the us iv will not retract?? it gets stuck on valve and when we can get it loose, then there is blood everywhere.We have had this happen several times.".
Additional Manufacturer Narrative
H6: investigation summary: bd received a 20 gauge insyte autoguard blood control unit from lot 0169618 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed that the needle was partially retracted.The activation button was depressed but retraction was not successful.Upon further inspection, it was determined that the base of the hub was caught on the lip creating a connection between the grip and barrel.Based off the visual inspection the engineer was able to verify the reported defect.It was determined that this was caused by a misalignment between the plug and the grip.The manufacturing facility has been notified of this incident and the findings.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12140283
• Report Number: 1710034-2021-00560
• Device Sequence Number: 19883609
• Product Code: FOZ
• UDI-Device Identifier: 30382903825371
• UDI-Public: 30382903825371
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K110443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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
• Operator of Device: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: 382537
• Device Catalogue Number: 382537
• Device Lot Number: 0169618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1