MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) INSYTE-W; INTRAVASCULAR CATHETER

Catalog Number	381312
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
They tell us that the catheter connection (threaded joint) does not seem to be properly secured and is leaking saline.Batch: 5337999 of 1.We have a customer who has informed us that the latest box they received of insyte w aletas 24g yellow - ref.381312 is causing them problems.This customer has been purchasing the product regularly since 2020 and had never complained before.They tell us that the catheter connection (thread) does not seem to fit properly and is leaking saline.Batch: 5337999, dated 30/11.When did the incident occur? before use.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: INSYTE-W
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• 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: 25473306
• Report Number: 8041187-2026-00026
• Device Sequence Number: 13368509
• Product Code: FOZ
• UDI-Device Identifier: 00382903813124
• UDI-Public: (01)00382903813124(11)251208(17)301130(10)5337999
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K151698
• 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,Followup
• Report Date (Section B): 07/08/2026

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: 381312
• Device Lot Number: 5337999
• 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: 05/28/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown