MAUDE Adverse Event Report: BECTON DICKINSON INSYTE YEL 24GA X 0.75IN; INTRAVASCULAR CATHETER

Catalog Number	381212
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 yel 24ga x 0.75in - 381212 - catheter defective / damaged.When screwing in the bi-directional valve after catheter insertion (functional line), the device jams without being able to screw in.Additional plastic element on the catheter thread.Bcatheter change.Repetitive invasive care for the same child, pain and risk of damaging the vein.The device has not preserved.
Additional Manufacturer Narrative
Our quality engineer inspected the photo submitted for evaluation.The reported issue of adapter/ connector defective/ damaged was confirmed upon inspection of the photo.The assembly process was reviewed.A possible root cause is a minor height offset between the picker and the gripper, which caused the gripper to slightly crush the outer luer thread when the part was seated at an incorrect height (too high or too low).This most likely caused damage to the outer luer thread.Another potential cause is over-threading with an external device during use, which could exacerbate or cause similar damage.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: INSYTE YEL 24GA X 0.75IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22816957
• Report Number: 2243072-2025-01003
• Device Sequence Number: 5751710
• Product Code: FOZ
• UDI-Device Identifier: 00382903812127
• UDI-Public: (01)00382903812127(11)241226(17)291130(10)4361246
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: 381212
• Device Lot Number: 4361246
• 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: 09/17/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown