MAUDE Adverse Event Report: BECTON DICKINSON INSYTE-W; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	381312
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that we notice a problem with the bd insyte-w with lot 5204426 catheter needles.The transition between catheter and connection is leaking.This has been noticed by several nurses.We are going to try to keep track of defective catheters.Our pediatrics department has established that the bd insyte-w 24g x 19mm (ref 381312) is a quality issue in lot 5204426.Is this something you have already heard from others?.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the photo submitted for evaluation.The reported issue of leakage was not confirmed upon inspection of the photo.Bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.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-W
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24861506
• Report Number: 2243072-2026-00277
• Device Sequence Number: 21451562
• Product Code: FOZ
• UDI-Device Identifier: 00382903813124
• UDI-Public: (01)00382903813124(11)250723(17)300630(10)5204426
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 04/21/2026

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: 5204426
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown