MAUDE Adverse Event Report: BECTON DICKINSON KIT PERISAFE 18GA 3-1/2IN WEISS; ANESTHESIA CONDUCTION KIT

Catalog Number	400273
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
It is reported leakage.Event description: after inserting the catheter leakage found in the dressing.Additional information: no patient were infected.Leakage will affect the dosage and action of drug.
Additional Manufacturer Narrative
One photo was received by our quality team for evaluation.Based on the image, bd is unable to confirm the reported failure.The photo does not provide sufficient evidence to determine whether the catheter malfunctioned and is inconclusive regarding the reported issue.No physical sample was submitted for evaluation.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, a root cause could not be determined as the incident could not be verified.This incident has been added to our database of reported incidents.
Event or Problem Description
No additional information.

• Brand Name: KIT PERISAFE 18GA 3-1/2IN WEISS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22903094
• Report Number: 2618282-2025-00089
• Device Sequence Number: 21045534
• Product Code: CAZ
• UDI-Device Identifier: 00382904002732
• UDI-Public: (01)00382904002732(17)280430(10)3111046
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K210978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• 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: 400273
• Device Lot Number: 3111046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown