MAUDE Adverse Event Report: BECTON DICKINSON INSYTE-W WINGED YEL 24GA X 0.75IN; 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	08/21/2025
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-w winged yel 24ga x 0.75in--leakage.Verbatim: there is bleeding at the connection between the end of the catheter and the infusion needle.
Additional Manufacturer Narrative
Our quality engineer inspected the photo, video, and sample submitted for evaluation.The reported issue of leakage was not confirmed upon inspection of the sample.Analysis of the sample showed a minor dent on the catheter adapter inner luer.The sample was subjected to a catheter leak test, and it passed with no abnormalities observed.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 root cause for the leak could not be determined as the defect was not replicated.Based on the complaint history review, this is the first complaint reported for leakage for this lot.This is most likely an isolated case.The assembly process was reviewed; the dent was suspected to be caused by the pick and place tool which was lose and hit the luer area when picking the adapter from the pallet.Corrective action was taken for the inner luer dent defect.An additional monthly preventative maintenance task for created to check and replace the rotary mechanism, if necessary.

• Brand Name: INSYTE-W WINGED YEL 24GA X 0.75IN
• 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: 22888483
• Report Number: 2243072-2025-01054
• Device Sequence Number: 14664934
• Product Code: FOZ
• UDI-Device Identifier: 00382903813124
• UDI-Public: (01)00382903813124(11)240531(17)290531(10)4146832
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: 381312
• Device Lot Number: 4146832
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown