MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE-W WINGED BL 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381323
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte-w winged bl 22ga x 1.0in leaked (b)(6) 2025 10: 38, in the central operating room, the 12th operating room performed a left cerebellar pontine angle lesion resection on the patient (b)(6).Intraoperative monitoring of invasive blood pressure was required, and a disposable intravenous indwelling needle was used to puncture the right dorsalis pedis artery.The puncture and needle core placement were successful, but then it was found that there was continuous bleeding from the junction of the catheter and needle.After the catheter was removed, pressure was applied to stop the bleeding, and the indwelling needle was replaced to puncture the left dorsalis pedis artery.Anesthesia and surgery then proceeded smoothly.This patient had difficulty with arterial puncture, and re-puncture increased the patient's pain.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the reported batch.From the returned photo, observed adapter connected with external connector was attached on user.However, unable to perform complete evaluation on the catheter adapter and tubing as some parts were blocked with blood stain.Actual sample was needed to evaluate if there is damage on the catheter tubing to establish the root cause.As current control, there is a functional test in place to check for catheter leakage.There is also in-process visual inspection in place to check for adapter and catheter tubing damage which could cause leakage.As no actual sample is returned for evaluation, root cause could not be established.

• Brand Name: BD INSYTE-W WINGED BL 22GA X 1.0IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21277505
• Report Number: 2243072-2025-00033
• Device Sequence Number: 7891843
• Product Code: FOZ
• UDI-Device Identifier: 00382903813230
• UDI-Public: (01)00382903813230(11)240403(17)290331(10)4084140
• 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
• Report Date (Section B): 01/15/2025

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: 381323
• Device Lot Number: 4084140
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown