MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOG BC YEL 24GA X 0.75IN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	382512
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number 382512 and lot number 4276449.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.Based on the available information, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported by customer that once catheter is inserted and they press the safety button, the needle does not retract.Verbatim: material # 382512, batch # 4276449.Similar to the recent iag / iagbc recall with other sku's, the clinicians report that once catheter is inserted and they press the safety button, the needle does not retract.This happened three times in the past day with this sku/ this lot #.Customer response on 29-may-2025.1.When you pressed the button, did the needle fully retract? no.2.Did the needle retract slower than normal? no, it did not retract.3.Did the needle start retracting and then stop, leaving the needle exposed ? no.4.Did the needle not move at all after pressing the button? correct.5.Did the button depress? no.

• Brand Name: INSYTE AUTOG BC YEL 24GA X 0.75IN
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: 22197786
• Report Number: 1710034-2025-00997
• Device Sequence Number: 12918834
• Product Code: FOZ
• UDI-Device Identifier: 00382903825127
• UDI-Public: (01)00382903825127(11)241004(17)270930(10)4276449
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2025

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: 382512
• Device Lot Number: 4276449
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown