MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD AS LVP 20D CV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	11426965
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd as lvp 20d cv - has a damaged luer and separated at the connection to the patient.The following information was provided by the initial reporter: tubing disconnected from patient and found to have a piece of the luer lock connector broken off.Describe any patient harm, injury, complication or negative outcome that occurred because of the event.No patient harm identified at this time.Did the event lead to any leak/spill? no.
Additional Manufacturer Narrative
It was reported that the luer lock had broken off.Three samples model 11426965 with possible lots 23085362, 23085441, and unknown were returned for investigation.The sets were examined for defects and abnormalities.The tubing was not connected to a male luer.No other defects or abnormalities were observed.Upon visual inspection under the microscope the tubing showed no signs of solvent.The customer complaint was verified and a quality notification was sent to the manufacturer.A dhr was done for model 11426965, possible lots 23085362, 23085441.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.From the manufacturing investigation, the most probable root cause of separation between tubing and male luer could be related to the incorrect solvent application by the assembler or due opportunities with the solvent dispenser.As a corrective action, the procedure was updated on november 09th, 2023 to improve cleaning and maintenance.A quality alert was created and communicated on april 02nd, 2023, to the involved personnel to reinforce the standard work instruction and the correct amount of solvent application.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.H3 other text : see h10 below.
Event or Problem Description
No additional info.

• Brand Name: BD AS LVP 20D CV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• 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: 18722304
• Report Number: 9616066-2024-00249
• Device Sequence Number: 6292207
• Product Code: FPA
• UDI-Device Identifier: 50885403232556
• UDI-Public: (01)50885403232556
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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: 11426965
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 05/01/2024
• 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