MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number	381444
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard gn 18ga x 1.16in leaked blood.The following information was provided by the initial reporter: blood leakage.
Additional Manufacturer Narrative
An additional lot number was provided in this complaint for material number 381444.Lot # 2290797.Mnf date 2022-11-02.Exp date 2025-09-30.Investigation: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history check was performed and this is the 1st related complaint reported with blood excess / splash / spill / exposure lot # 3017058 regarding item (b)(4).A complaint history check was performed and this is the 3rd related complaint reported with blood excess / splash / spill / exposure lot # 2290797 regarding item (b)(4).A device history record review was completed by our quality engineer team for provided material number 381444 and lot number 3017058 and 2290797.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.

• Brand Name: BD INSYTE AUTOGUARD
• Common Device Name: PERIPHERAL IV CATHETERS
• 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: 19800691
• Report Number: 1710034-2024-00755
• Device Sequence Number: 7386937
• Product Code: FOZ
• UDI-Device Identifier: 00382903814442
• UDI-Public: (01)00382903814442
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

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: Other
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 381444
• Device Lot Number: 3017058
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown