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

Catalog Number	10014914
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris syringe module syringe administration set was leaking the following information was received by the initial reporter with the following verbatim: it was reported by customer that versed gtt was leaking at nad site.Defect/complaint issue - versed gtt was leaking at nad site (line has been flushed w/ ns before attaching) lot number - (10)2403623.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Correction submitted for awareness date.Awareness date was 06/11/2024 for additional/ clarifying information received by customer to determine reportability.The versed gtt was infusing on a syringe pump and closest to the syringe where the nad and med line connect, the versed gtt was leaking.No noted injury, unsure if it effected the dose reaching the patient.--- received on 06/11/2024.
Event or Problem Description
Additional information received - please see h tab.Material # 10014914, lot # 2403623.It was reported by customer that versed gtt was leaking at nad site.Verbatim: rcc received a complaint via email.Email(s) attached.Complaint - (b)(4).Purchase order - (b)(4).Item number - 10014914.Defect/complaint issue - versed gtt was leaking at nad site (line has been flushed w/ ns before attaching) lot number - (10)2403623.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
It was reported by customer that product was leaking at nad site.One sample model 10014914, lot 24036238 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with water and no leaks were observed.The customer complaint was unable to be replicated.A root cause for the reported failure was determined because the failure could not be replicated.A device history record review for model 10014914 lot number 24036238 was performed.The search showed that a total of 24,003 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.

• Brand Name: BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION 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: 19687181
• Report Number: 9616066-2024-00955
• Device Sequence Number: 7006304
• Product Code: FPA
• UDI-Device Identifier: 10885403233906
• UDI-Public: (01)10885403233906(11)240325(17)270325(10)24036238
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• 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,Followup
• Report Date (Section B): 09/09/2024

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: 10014914
• Device Lot Number: 24036238
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 09/09/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 07/09/2024; 09/09/2024
• 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