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

Catalog Number	382512
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autog bc foreign matter.The following information was provided by the initial reporter: i¿m reaching out a safety incident that involved bd item # 382512 (insyte autoguard bc shielded iv catheters, wingless, yellow, 24g x 0.75").Please see noteworthy event details below: description: mold vs.Staining noted on needle retraction button on 24g straight bd insyte autoguard bc iv, that needle was not used on patient, new iv package from different lot # was used.That needle and packaging (as well as all 24g iv from that lot #) was removed and saved for further investigation.Management was emailed to make aware.Equipment: 25g x 0.75 in (0.7 x 19 mm) bd insyte autoguard bc, expiration date: 2025-12-31, lot #: 3005946.Manufacture date: 2023-01-01.The event occurred on 3/31/2025.Harm level: no harm to patient or clinical staff, as product was not used.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
The complaint that the white button was discolored was confirmed and the cause appeared to be manufacturing related.The 24g insyte autoguard device was received with what was likely discolored/burnt resin that was embedded within the molded button that activates the safety mechanism.No foreign material was observed within the fluid path, and the discoloration appeared to be a cosmetic issue.The appropriate manufacturing personnel were notified of this issue.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
Event or Problem Description
No new information.

• Brand Name: BD INSYTE AUTOG BC
• 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: 22501562
• Report Number: 1710034-2025-01182
• Device Sequence Number: 15197300
• Product Code: FOZ
• UDI-Device Identifier: 00382903825127
• UDI-Public: (01)00382903825127(17)251231(10)3005946
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: 12/31/2025
• Device Catalogue Number: 382512
• Device Lot Number: 3005946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown