MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS PUMP MODULE SMARTSITE INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	11426965
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
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.
Event or Problem Description
It was reported that bd alaris pump module smartsite infusion set was damaged the following information was received by the initial reporter with the following verbatim primary 5-port iv tubing was inspected by rn.Rn noticed crack in luer lock connector.Tubing disconnected from patient.No packaging with lot # available.
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.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.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.H3 other text : see h10 below.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
• 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: 18740585
• Report Number: 9616066-2024-00261
• Device Sequence Number: 17741500
• 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: Other Health Care Professional
• 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: Other
• Device Catalogue Number: 11426965
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• 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: 02/20/2024
• Supplement Report FDA Received Date: 04/24/2024
• 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