MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD 10 INCH EXT W/ 0.2 PED & VLV PORT; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	20029E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
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 10 inch ext w/ 0.2 ped & vlv port leaked.The following information was provided by the initial reporter: we had a tpn tubing number (b)(4) lot number h37020029e1a leaking at the filter.(b)(6) 2024.1.Are you able to provide the dates of the events in the format of mm-dd-yyyy? if unknown, can state unknown.(b)(6) 2024.2.How was the patient outcome? are there any clinical signs, health consequences or impact? no harm evident, physical or otherwise.3.Any adverse event or serious injury reported to patient or health care professional? no.
Additional Manufacturer Narrative
Investigation results: it was reported that the set was leaking at the filter.Two samples model 20029e, lot 24036092 was returned for investigation, the sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were connected to a 10 ml bd syringe and flushed with water.No observation of leakage at the filter was observed.Additionally, air under water test was performed.The set was pressurized with about 10 psi and the vent was submerged under water.There was a steady stream of air bubbles coming from the filter vent.This would indicate that there is no issue with damage/ holes in the membrane.The reason for the membrane leaking is that the hydrophobicity of the membrane must have been compromised during use and not during the manufacturing process.A device history record review for model 20029e lot number 24036092 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25mar2024.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.
Event or Problem Description
No additional information.

• Brand Name: BD 10 INCH EXT W/ 0.2 PED & VLV PORT
• 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: 20410544
• Report Number: 9616066-2024-01455
• Device Sequence Number: 18115966
• Product Code: FPA
• UDI-Device Identifier: 10885403234866
• UDI-Public: (01)10885403234866
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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: 20029E
• Device Lot Number: 24036092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown