MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD; INTRAVASCULAR CATHETER

Catalog Number	381512
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Patients had to be stuck twice, a new product had to be obtained in each instance.
Additional Manufacturer Narrative
Correction: additional information received on 25 march 2025, was not captured in the initial mdr.F code updated.Initial reporter occupation updated.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the samples submitted for evaluation.Your report of a damaged catheter was confirmed and the cause appeared to be associated with use.The returned 24 g insyte autoguard iv catheters exhibited evidence of use.The needles were not returned with the catheters.A microscopic examination of the iv catheter revealed a v-shaped breach in each tubing near the pink adapter.The size and direction of the breach was consistent with needle puncture damage.As the sample exhibited evidence of use, the damage likely occurred due to complications during the insertion process.Had the iv catheter been punctured by the needle during assembly/manufacturing, the resultant damage would have precluded venous access.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte autoguard winged yel 24ga x.75in catheter tip integrity.It was reported by customer that the piv was placed and met with resistance at insertion.The catheter was sheared at the tip for both instances and removed from patient.Verbatim: i have two products, same lot 4183871.In both cases, the piv was placed and met with resistance at insertion.The catheter was sheared at the tip for both instances and removed from patient.

• Brand Name: INSYTE AUTOGUARD
• Common Device Name: INTRAVASCULAR 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: 21741453
• Report Number: 1710034-2025-00500
• Device Sequence Number: 21030187
• Product Code: FOZ
• UDI-Device Identifier: 00382903815128
• UDI-Public: (01)00382903815128(11)240703(17)270630(10)4183871
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 06/16/2025

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: 381512
• Device Lot Number: 4183871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: Not provided; 06/16/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/14/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown