MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC PRO WINGED, 20G X 1.16"; INTRAVASCUALR CATHETER

Catalog Number	392634
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd insyte autoguard bc pro winged, 20g x 1.16" there was damage to the wings.This occurred 10 times.There was no report of patient impact.The following information was provided by the initial reporter: wings on the catheter are bent inside the package.They have noticed this on approximately 10 catheters.
Event or Problem Description
It was reported while using bd insyte autoguard bc pro winged, 20g x 1.16" there was damage to the wings.This occurred 10 times.There was no report of patient impact.The following information was provided by the initial reporter: wings on the catheter are bent inside the package.They have noticed this on approximately 10 catheters.
Additional Manufacturer Narrative
H.6.Investigation summary: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed a pink catheter adapter.The insyte autoguard catheter tubing was pinched between the thumb and forefinger and no portion of the tubing was visible.The catheter had been removed from the needle.It appeared that one of the wings on the catheter adapter was bent therefore confirms the reported issue.Since the catheter had been removed from the needle, the deformation may have inadvertently occurred during handling.The damage may have also occurred during storage, transit, or during manufacturing.The observable features on the submitted photograph did not contain enough information to identify a specific root cause of the reported event.Examination of the actual product involved may provide clarification as to the cause for the reported failure.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.

• Brand Name: BD INSYTE AUTOGUARD BC PRO WINGED, 20G X 1.16"
• Common Device Name: INTRAVASCUALR 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17484958
• Report Number: 1710034-2023-00890
• Device Sequence Number: 7246471
• Product Code: FOZ
• UDI-Device Identifier: 00382903926343
• UDI-Public: (01)00382903926343
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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: 01/31/2026
• Device Catalogue Number: 392634
• Device Lot Number: 3129529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• 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