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

Catalog Number	381512
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter experienced (short description of event).The following information was provided by the initial reporter: i just recently had the same nurse who reported this complaint report that the same exact incident happened with another iv catheter with the same lot number during another infusion.It was reported by the customer that the nurse tried to attach the extension tubing to the iv catheter there was leaking around the point where the catheter and tubing connect.
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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: (b)(6), 2023 h6: investigation summary bd received two used 24 gauge insyte autoguard units from lot 2069343 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 units and observed no visible damage or deformities.Next, the engineer performed a water/air leak test on each unit.Each unit passed and no leakage was observed.Therefore, based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no defects were found during inspection a definitive root cause could not be determined.H3 other text : see h10.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter experienced (short description of event) the following information was provided by the initial reporter: i just recently had the same nurse who reported this complaint report that the same exact incident happened with another iv catheter with the same lot number during another infusion.It was reported by the customer that the nurse tried to attach the extension tubing to the iv catheter there was leaking around the point where the catheter and tubing connect.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16705182
• Report Number: 1710034-2023-00389
• Device Sequence Number: 17063033
• Product Code: FOZ
• UDI-Device Identifier: 00382903815128
• UDI-Public: 00382903815128
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/09/2023

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: 02/28/2025
• Device Catalogue Number: 381512
• Device Lot Number: 2069343
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 04/08/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• 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