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

Model Number	381444
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 while using the bd insyte¿ autoguard¿ shielded iv catheter the needle pierced the catheter.The following information was provided by the initial reporter: verbatim: rn went to start iv and the needle would not retract, needle and catheter was pulled out and the needle was protruding through the side of the catheter.No harm to patient other than needed stuck again.Additional info from customer: ((b)(6)2023).The needle had pierced the catheter.The kinking had to do with the needle not disengaging and getting caught on way out.
Event or Problem Description
It was reported that while using the bd insyte¿ autoguard¿ shielded iv catheter the needle pierced the catheter.The following information was provided by the initial reporter: verbatim: rn went to start iv and the needle would not retract, needle and catheter was pulled out and the needle was protruding through the side of the catheter no harm to patient other than needed stuck again additional info from customer: (07-july-2023) the needle had pierced the catheter the kinking had to do with the needle not disengaging and getting caught on way out.
Additional Manufacturer Narrative
H6: investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Dhr was reviewed for all reported defects.Since, an investigation could not be performed bd was unable to determine a possible root cause.H3 other text : see h10.

• 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: 17329683
• Report Number: 1710034-2023-00799
• Device Sequence Number: 5537002
• Product Code: FOZ
• UDI-Device Identifier: 30382903814443
• UDI-Public: (01)30382903814443
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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: 01/31/2026
• Device Model Number: 381444
• Device Catalogue Number: 381444
• Device Lot Number: 3039537
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• 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