MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE-W WINGED GN 18GA X 1.88IN; INTRAVASCULAR CATHETER

Catalog Number	381347
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte-w winged gn 18ga x 1.88in had foreign matter (b)(6) 2025 8:10 while performing intravenous puncture on patient in operating room no.2, foreign matter was found in the sheath tube of the intravenous catheter.The cannula was immediately replaced, and the patient was not affected.
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
No photos or samples were received by our quality team for evaluation.Therefore, the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis of the affected device.Current controls, there are outgoing and in-process visual inspection in place to check for foreign matter.There is also a 4-hourly housekeeping in place to clean all the machine mechanisms in direct contact with products with alcohol.Examination of the product involved may provide clarification as to the cause for the reported failure.

• Brand Name: BD INSYTE-W WINGED GN 18GA X 1.88IN
• 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 NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22559699
• Report Number: 2243072-2025-00897
• Device Sequence Number: 9473913
• Product Code: FOZ
• UDI-Device Identifier: 00382903813476
• UDI-Public: (01)00382903813476(11)240607(17)290531(10)4159610
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 381347
• Device Lot Number: 4159610
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown