MAUDE Adverse Event Report: BECTON DICKINSON INSYTE-N WINGED YEL 24GA X 0.56IN; INTRAVASCULAR CATHETER

Catalog Number	381311
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2025
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-n winged yel 24ga x 0.56in-needle through catheter.Date of occurrence: (b)(6) 2025.Insertion of peripheral venous catheters in two premature babies in the department when removing the canula and then reinserting it, the canula pierced the catheter on the wall, making it impossible to insert this catheter.Clinical consequences observed: necessity to replace with another batch number.
Additional Manufacturer Narrative
Our quality engineer inspected the photos and 2 samples submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the samples.Analysis of the samples showed the needle had pierced through the catheter.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.The assembly process was reviewed.If the needle had pierced through the catheter during the manufacturing process, the defect would be detected and auto rejected by the 100% inline tip spear vision inspection system.Needles can pierce through the catheter during product application, when the product was manipulated, or during needle cover removal if not done carefully.

• Brand Name: INSYTE-N WINGED YEL 24GA X 0.56IN
• 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: 23029982
• Report Number: 2243072-2025-01151
• Device Sequence Number: 21127450
• Product Code: FOZ
• UDI-Device Identifier: 00382903813117
• UDI-Public: (01)00382903813117(11)250301(17)300228(10)5057196
• 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): 10/29/2025

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: 381311
• Device Lot Number: 5057196
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown