MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD GN 18GA X 1.16IN; PERIPHERAL IV CATHETER

Catalog Number	381844
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.Investigation summary: upon investigation, no photos or physical samples were provided to display the reported condition.Our quality engineer team conducted a device history record review for material number 381844 and lot number 3342321.The review did not uncover any abnormalities during the production process that could have caused the defect, and all quality tests were within specification.It was noted that the product in question does not contain the blood control valve technology associated with the reported event and material number.Despite the available information, the exact cause of the incident remains unidentified.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Material#: 381844 batch#: 3342321 it was reported that the bd insyte autoguard gn 18ga x 1.16in does not have the valve to prevent backflow of blood once placed in vein.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.Does not have valve to prevent backflow of blood once placed in a vein.

• Brand Name: BD INSYTE AUTOGUARD GN 18GA X 1.16IN
• Common Device Name: PERIPHERAL IV 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19792192
• Report Number: 1710034-2024-00750
• Device Sequence Number: 7096781
• Product Code: FOZ
• UDI-Device Identifier: 00382903818440
• UDI-Public: (01)00382903818440
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2024

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 Catalogue Number: 381844
• Device Lot Number: 3342321
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown