MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXGUARD EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	ME1225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxguard extension set was damaged.The following information was received by the initial reporter with the verbatim: please see two other product incident reports for our me1225 micron filter.Leaking from circle on filter.I just had an issue reported from this weekend to me about the lipid filter "occluding" after being paused for an infusion and the nurse tried to flush it.When he tried to flush it, the filter broke open and lipids leaked everywhere.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
The customer reported occlusion in lipid filters, and that they 'broke' open when trying to flush.There were 2 used samples of material me1225 and lot 23029211 returned.The sets were visually examined for defects and abnormalities.No defects or abnormalities were observed, just tape from the customer pointing to the air vent.The sample was tested in lab by priming with water, and the filter showed no signs of occlusion, but there was leakage from all around the filter.The occlusion and flushing by the customer seemed to have busted open the filter at the seams and the leakage was coming from in between the top and bottom pieces of the filter.The filters were sent out to the filter supplier, and they found the root cause to be welding inconsistencies that was not caught by their process.They have since instituted a vision system the ensures accuracy in the line to detect weld inconsistencies in the filters.They have also moved production of this part number to a new work center.Device history record review for model me1225 lot number 23029211 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13feb2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD MAXGUARD EXTENSION 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: 17917319
• Report Number: 9616066-2023-02050
• Device Sequence Number: 19578830
• Product Code: FPA
• UDI-Device Identifier: 10885403236129
• UDI-Public: (01)10885403236129
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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 Expiration Date: 02/13/2026
• Device Catalogue Number: ME1225
• Device Lot Number: 23029211
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown