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

Catalog Number	381512
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E1.Address information was not provided, therefore, xx was used as a place holder.
Event or Problem Description
It was reported that bd the following information was provided by the initial reporter: after insertion of the catheter and while attempting to thread the neutral connector, or cap, onto the catheter, i noticed that the cap would not slide into the groove of the iv catheter.After removing the iv catheter from the patient, i noticed the edge of the catheter had an extra high edge.8 oct to answer your questions there was not any injury to report and there wasn't a serious injury to the patient.This occurred to me with one patient.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs of the implicated 24g winged autoguard iv catheter, which showed a deformed thread on the yellow catheter adapter.The affected thread was located on the side of the adapter with the push-off tab.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to a misalignment with equipment.A device history record review showed an in-process sampling where damage was seen on the nose and threads of the catheter adapters during part of the production of this batch.The misalignment was addressed, and a random sampling was performed where the units passed and were then released.

• Brand Name: BD INSYTE AUTOGUARD WINGED
• 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: 20529164
• Report Number: 1710034-2024-01198
• Device Sequence Number: 9088263
• Product Code: FOZ
• UDI-Device Identifier: 00382903815128
• UDI-Public: (01)00382903815128(11)240122(17)261231(10)4012528
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: 381512
• Device Lot Number: 4012528
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown