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

Model Number	392523
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc pro shielded iv catheter leaked fluid at the hub connection during the infusion.The following information was provided by the initial reporter: "on 7/26 a 22g 1 inch bd instyle autogaurd bc pro was placed on our patient in the left forearm.Iv inserted, flash noted and catheter threaded without complication, needle retracted with safety button.Some blood noted at insertion site but did not return after cleaned up.Iv flushed without complication no leaking noted at this point.Secured with tagederm and tape.Fluids running slow tko.After about 10 minutes patient called staff in and leaking noted when we attempted to see if hub needed to be secured that is when it was noticed fluid was leaking was where hub meets catheter.Fluids stopped immediately and concern was that catheter would dislodge from hub, we slowly removed iv catheter without any issue.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval: yes.D.9.Returned to manufacturer on: 03-aug-2022.H.6.Investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one used 22g x 1.00in.Insyte autoguard bc pro unit from lot number 1328318.Through the initial inspection, damage was not observed with any of the components.The unit was leak tested where a leak was identified just above the nose of the adapter.Further microscopic inspection found that an angled tear was present in the shape of two arches connecting.The reported issue was confirmed.Based on the location of the damage and the observed characteristics, it is likely that the reported defect originated in manufacturing during swaging of the unit.During the swaging process the tubing is placed over a pin and may get pinched or nicked.Operators perform a leak test of the final assembly per the sampling and quality plans to mitigate the occurrence of this defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.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.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc pro shielded iv catheter leaked fluid at the hub connection during the infusion.The following information was provided by the initial reporter: "on 7/26 a 22g 1 inch bd instyle autogaurd bc pro was placed on our patient in the left forearm.Iv inserted, flash noted and catheter threaded without complication, needle retracted with safety button.Some blood noted at insertion site but did not return after cleaned up.Iv flushed without complication no leaking noted at this point.Secured with tagederm and tape.Fluids running slow tko.After about 10 minutes patient called staff in and leaking noted when we attempted to see if hub needed to be secured that is when it was noticed fluid was leaking was where hub meets catheter.Fluids stopped immediately and concern was that catheter would dislodge from hub, we slowly removed iv catheter without any issue.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER
• Common Device Name: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15205702
• Report Number: 1710034-2022-00428
• Device Sequence Number: 2108899
• Product Code: FOZ
• UDI-Device Identifier: 00382903925230
• UDI-Public: 00382903925230
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 392523
• Device Catalogue Number: 392523
• Device Lot Number: 1328318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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
• Patient Sex: Unknown