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

Catalog Number	381533
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One event, unknown lot: "2 lots for the iv 20g 1.0 catheter 5037127 and 5087722, pulled another 20g i inch iv catheter to use and the wrappers got mixed up".H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd insyte autoguard winged catheter shreded.The following information was provided by the initial reporter: injuries or adverse event: yes.Surgery, today (b)(6) 2025, had an incident with a 20g bd insyte autoguard winged 20g x 1.00in ref 381533, the iv 20g 1.0 catheter sheared into the patient¿s vein when the iv advanced, when retracted the sheared pieces came back out, this incident was in the pre-op room.
Additional Manufacturer Narrative
Our quality engineer inspected the photographs submitted for evaluation.Your report of a damaged catheter could not be confirmed from the two photographs that were provided for investigation.The photos showed unit packaging and one 20g insyte autoguard iv catheter.The resolution and details of the photo lacked evidence to confirm any damage.Without the physical sample, the features of the catheter tubing could not be analyzed.The reported issue can occur from needle puncture damage; however, the root cause could not be determined.Although the lot number of the report was not confirmed, two lot numbers were provided in which a device history record was performed.The device history record review showed no non-conformances associated with this issue during the production of these batches: 5037127 and 5087722.
Event or Problem Description
No new information.

• Brand Name: 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: 22811919
• Report Number: 1710034-2025-01346
• Device Sequence Number: 20792780
• Product Code: FOZ
• UDI-Device Identifier: 00382903815333
• UDI-Public: (01)00382903815333(11)250208(17)280131(10)5037127
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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 Catalogue Number: 381533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown