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

Catalog Number	381444
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while inserting bd insyte¿ autoguard¿ shielded iv catheter tip split around stylus.The following was received by the initial reporter: rn inserting iv catheter when noted tip split around stylus.
Additional Manufacturer Narrative
A.2.Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.E.4.Fda notified: the initial reporter also notified the fda via medwatch# [2700490000-2023-8005].H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up emdr for device evaluation: one used sample was provided to our quality team for investigation.Functional testing was performed and a tear in the tubing, consistent with needle tip damage, was observed.A device history review was performed for reported lot 3025561, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.A vision system is used to detect damage to the device, no issues were found during manufacturing for the reported lot.Based on the sample evaluation and our quality team's investigation, we cannot identify a root cause related to our manufacturing process at this time.It is likely the tear occurred during the insertion of the device.Complaints received for this product and reported 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.
Event or Problem Description
Rcc received a complaint via email.Email(s) attached 29 yo fe g3/p0 being prepped for c-section: rn inserting iv catheter when noted tip split around stylus.Patient required 2nd insertion/puncture.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17541477
• Report Number: 1710034-2023-00913
• Device Sequence Number: 7421009
• Product Code: FOZ
• UDI-Device Identifier: 30382903814443
• UDI-Public: (01)30382903814443
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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: Health Professional
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 381444
• Device Lot Number: 3025561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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 Age: 29 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Race: White