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

Catalog Number	10241342
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris extension set was damaged the following information was received by the initial reporter with the following verbatim: it was reported by customer that the amber tubing does not consistently seat properly with the lipid filters (bd (b)(4)).This has been found on 4 patients.The ends of the lipid filters seem to have a different color plastic and make a friction noise when connected.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Additional information: initially it has been mentioned as "this has been found on 4 patients".Could you please confirm all happened in same day? if it had happened in different days, please provide all date of events in format mm-dd-yyyy?? i do not have the specific incidence dates.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.It was noted no harm came to patient.No additional labs drawn no infection noted around incident.
Additional Manufacturer Narrative
Investigation results: it was reported that the set would not connect properly to the filter tubing.Two samples model 10241342, lot 24049060 were returned for investigation along with two samples model 20129e, lot 241049319 from (b)(4).The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The 10241342 sets were connected to the 20129e extension sets.The sets were flushed with water.No leak was observed.An air under water pressure test was performed at around 10 psi.No leak was observed from the connection of the two sets.The customer complaint was unable to be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 10241342 lot number 24049060 was performed.The search showed that a total of (b)(4) in 1 lot number was built on (b)(6)2024.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 ALARIS 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: 19828536
• Report Number: 9616066-2024-01033
• Device Sequence Number: 7514133
• Product Code: FPA
• UDI-Device Identifier: 10885403234170
• UDI-Public: (01)10885403234170(11)240402(17)270402(10)24049060
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 12/09/2024

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: 10241342
• Device Lot Number: 24049060
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown