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

Catalog Number	381012
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer states" various pivc inserters from radiation oncology unit have experienced b;ood control failure on the 22g and difficulty inserting 24g- excessive resistance to needle entry.Nurses state, needle looks blunt.Cnc vase examined 24g and states there is an obvious flaw in plastic catheter which would result in painful or failed cannulation 24-oct-2025 - received an email response from complainant.Could you please confirm if the course of treatment changed due to event? no.Could you please confirm if there was any exposure to blood/bodily fluid? yes.As the safety valve had a defect, there was blood return from the pivc but nurses were following the correct procedure by using universal precautions.Could you please confirm if this is a safety issue? if a nurse is cannulating a patient who is on cytotoxic precautions and there is a blood spill; or if nurses are not following procedures using universal precaution.Not mention exposure to hepatitis/hiv patients.Could you please confirm if any other actions were taken? vase and quality department notified.Rtu nurses notified and aware of the possible problems.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Our quality engineer inspected the samples for evaluation.Your reported issue of blood control failure and resistance to needle entry could not be confirmed from the representative 24g insyte autoguard devices that were provided for investigation.A functional test of the unused 24g insyte autoguard devices revealed that the blood control valve functioned as designed.The needle tip penetration test showed that the force required for penetration was within specification.No damage or defects were identified on the returned samples.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
No new information.

• Brand Name: INSYTE AUTOG BC GLOBAL
• 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: 23402213
• Report Number: 1710034-2025-01674
• Device Sequence Number: 13273619
• Product Code: FOZ
• UDI-Device Identifier: 00382903810123
• UDI-Public: (01)00382903810123
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: 381012
• Device Lot Number: 5051387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown