MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD 166-IN 15 DROP ADMIN/REMOVABLE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MX4436
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 166-in 15 drop admin/removable tubing separates from drip chamber.The following information was provided by the initial reporter: while transporting between departments the tubing separated from drip chamber mid transport 12 april response disconnect happened as patient was wheeling out of or into pacu.There was no injury to patient.
Additional Manufacturer Narrative
It was reported that the tubing separated from the drip chamber.One used and one unused sample model mx4436, lot 24019107 was returned for investigation.The sets were examined for defects and abnormalities.The used sample was separated from the drip chamber and the drip chamber was not returned.No defects or abnormalities were observed.No issues were found was the unused set.The used set was inspected under a microscope and lack of solvent was sent at the tubing that connects to the drip chamber.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the possible root cause of separation tubing/drip chamber in the model mx4436 is the incorrect solvent application method by the assembler.A quality alert was created on may 06th, 2024 to communicate the failure and reinforce the correct solvent application method and avoid the lack of solvent/separation.A device history record review for model mx4436 lot number 24019107 was performed.The search showed that a total of 9003 units in 1 lot number was built on 08jan2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
No additional info.

• Brand Name: BD 166-IN 15 DROP ADMIN/REMOVABLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 19225842
• Report Number: 9616066-2024-00675
• Device Sequence Number: 20563730
• Product Code: FPA
• UDI-Device Identifier: 10885403237478
• UDI-Public: (01)10885403237478
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 06/19/2024

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: MX4436
• Device Lot Number: 24019107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown