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

Catalog Number	382533
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Needle Stick/Puncture (2462); Insufficient Information (4580)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We have received reports in regard to the bd insyte autoguard needles not retracting.The fda issued a recall, and we have identified an impacted ref # that was not included in the recall.Various reports that the needle did not retract fully and health providers were struck.Therapies being used on the patient at the time of the event that may have caused or contributed to the event: not applicable.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.G.4.K201075; k251654 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
Customer response on mar-30: can you please provide an exact date of event? (b)(6) 2026.What was the impact to the patient? iv/vein blew resulting in a missed iv attempt.The catheter tip is intact when withdrawn.The iv was preserved for evidence and given to chief nurse acute care.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Our quality engineer inspected the photographs submitted for evaluation.Your report of a damaged catheter was confirmed; however, the root cause could not be determined from the three photographs that were provided for investigation.The photos showed material consistent with an insyte autoguard device.The needle was protruding through the catheter tubing, which may have affected the reported inability to retract the needle.This type of damage can occur from reinserting the needle into the catheter during the placement procedure.Without the physical sample, the root cause of the reported event could not be determined.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Additional Manufacturer Narrative
Correction: upon further review it was determined that the annex e/f codes required update.Annex e/f 1 captures the inconclusive needlestick injury that was initially reported and in follow up indicated unknown if it occurred.Annex e/f 2 captures the reported blown vein reported related to the patient outcome.
Event or Problem Description
No additional 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: 24730799
• Report Number: 1710034-2026-00350
• Device Sequence Number: 18708575
• Product Code: FOZ
• UDI-Device Identifier: 00382903825332
• UDI-Public: (01)00382903825332(17)280831(10)5267705
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 382533
• Device Lot Number: 5267705
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: Not provided; 05/05/2026; 05/05/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/14/2026; 05/06/2026; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown