MAUDE Adverse Event Report: BECTON DICKINSON TRI-PORT EXT W/3 VLV PORTS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	20038E
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission with device evaluation.The customer reported the male end of port broke, and returned one sample of material 20038e, lot unknown.Visual inspection verified the luer crack on the sample, and the issue of component damage.The luer collar was completely off the rest of the luer, and had whitened plastic, cracks, and a chunk out of half of the top.Previous similar investigations have found that if the application of alcohol to either mating component was not allowed proper time to dry prior to connection, there was a higher chance of luer damage.Please allow around 30 seconds after alcohol wipe for dry time.A device history record review could not be performed on material 20038e because the lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
Material # 20038e batch # unknown it was reported by customer that noted 3-way port cracked/broken at male end side : rcc received a complaint via email.Email(s) attached.I have 1 each potentially defective tri port extension set 20038e.Lot number was not documented.1.What was the date and time of the event(s)? 3/26/2024 time unknown 2.Please confirm the tubing model/ref number? 20038e 3.How many tubings are you sending in to us for investigation? 1 4.When is the dislodge/separation being noticed? unknown 5.During priming? no 6.Directly out of the packaging? no 7.After being connected to a patient? 24 hours? 48 hours or 72 hours? unknown 8.What was infusing at the time of the event? unknown 9.Was the tubing connected to a patient? yes 10.Was there any patient harm? no 11.Did the patient require medical intervention because of the event? no 12.How did this occur? noted 3-way port cracked/broken at male end side that twists, no fluid leaking noted.3-way port still secured/connected to smart site at the time.13.What was infusing at the time of the event? unknown 14.Please clarify: did a secondary infusion flow into the primary drip chamber? unknown 15.Lot # unknown.

• Brand Name: TRI-PORT EXT W/3 VLV PORTS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19198284
• Report Number: 9616066-2024-00644
• Device Sequence Number: 20747859
• Product Code: FPA
• UDI-Device Identifier: 07613203011976
• UDI-Public: (01)07613203011976
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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: 20038E
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown