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

Catalog Number	381333
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
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 by customer that stylets are sticky when trying to advance.Also having a lot of the needles poking through the catheter.Observed issue: please provide a description of the observed issue: stylets are sticky when trying to advance.Also having a lot of the needles poking through the catheter.Customer response on 01-jun-2026.1.Can you please provide an exact date of event in format mm-dd-yyyy? this has been an ongoing issue with this lot number.Date i have photos from (b)(6) 2026.2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.- complication is the catheters seem sticky, we can¿t advance the catheter easily and the stylet is piercing through the flexible catheter.3.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? - i have 2 full boxes (100) plus an open box of catheters with the same lot numbers that we¿ve been struggling with.

• 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: 25488441
• Report Number: 8041187-2026-00028
• Device Sequence Number: 9930070
• Product Code: FOZ
• UDI-Device Identifier: 00382903813339
• UDI-Public: (01)00382903813339
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: 381333
• Device Lot Number: 5231336
• 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: 05/29/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown