MAUDE Adverse Event Report: BECTON DICKINSON INSYTE-W; 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	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte-w winged yel 24ga x 0.75in - leakage -mfg sg tuas.On (b)(6) 2025 at 14:40, the paediatric patient was administered 1 g of suprofen (cefoperazone/sulbactam) intravenously due to a respiratory tract infection.0.4 g iv infusion q12h.While the nurse was performing a central venous catheter insertion on the infant and successfully connecting the heparin cap, blood leakage was observed at the connection point between the catheter and the heparin cap.After replacing the heparin cap, the same issue persisted.The catheter was subsequently removed, and it was found that the leakage was caused by a minor crack in the catheter.A new catheter was inserted, resulting in injury to the infant.
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
This pr will be cancelled as it is a duplicate of (b)(4).
Additional Manufacturer Narrative
Following the submission of this mdr, it was noted that this pr is a duplicate of (b)(4) and will be cancelled.

• Brand Name: INSYTE-W
• 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: 22923727
• Report Number: 2243072-2025-01069
• Device Sequence Number: 18418800
• Product Code: FOZ
• UDI-Device Identifier: 00382903813124
• UDI-Public: (01)00382903813124
• 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): 09/03/2025

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown