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	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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: there was a leak in the tubing at the site of the transducer.It was leaking medication below the pump.Ancef was infusing.Delay in infusion and tubing change was required.Treatment was able to be completed.Patient status unaffected.
Additional Manufacturer Narrative
It was reported that there was a leak.One sample model 10014914 was returned for investigation.The set was examined for defects and abnormalities.The pressure disc film was ripped open.No other defects or abnormalities were observed.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's review of the complaint, according to customer words the condition reported was found during the infusion, this led us to not be able to confirm that the condition reported is related to manufacturing process.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
No additional info.

• 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: 19387230
• Report Number: 9616066-2024-00783
• Device Sequence Number: 15186652
• Product Code: FPA
• UDI-Device Identifier: 10885403233906
• UDI-Public: (01)10885403233906
• 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
• Report Date (Section B): 08/12/2024

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: UNKNOWN
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 08/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown