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	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
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 damaged the following information was received by the initial reporter with the following verbatim: rcc received a complaint via email.Email(s) attached.Product malfunction.
Additional Manufacturer Narrative
It was reported by customer that there is a product malfunction.Two samples were received for quality investigation.A visual inspection was conducted on the samples and one of the pressure sensing discs showed visible signs of being deformed.The second sample did not show any visible signs of damage.The samples were then sent to the manufacturing facility for additional investigation.The sample that showed the visible deformity of the pressure sensing disc film was investigated further and it was determined that the sample was previously used because there was liquid in the component.The sample was placed in a syringe pump and tested at a flow rate of 20ml/h.An occlusion alarm was set off after 20 minutes of the test.The infusion set was then inspected for further damages, but there were no indicated damages.The set was then placed back into the syringe pump and the simulated infusion was restarted.There were no further issues with this infusion set.For the second sample, no visual defects were identified, however, when conducting further investigation at the manufacturing location, damage under the pressure sensing disc film was identified.Leakage was discovered coming from the pressure sensing disc when conducting a simulated infusion.The potential root cause for the failure of the second set infusion set that leaked from the pressure sensing disc could be related to failures with the sealing activation sensor of the sensor disc assembly machine.Corrective actions have been implemented in order to address the issue.Work orders have been created to review the assembly equipment and conduct preventative maintenance to ensure the assembly equipment is working properly.A device history record review for model 10014914 lot number 23105097 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 05oct2023.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.H3 other text : see narrative below.
Event or Problem Description
No additional information was provided.Material #:10014914.Batch#:unknown.It was reported by customer that there is a product malfunction.Verbatim: rcc received a complaint via email.Email(s) attached.Product malfunction.My apologies for the issue experienced with 10014914.I will submit this to our product complaints team for investigation.A representative from that team will follow up to provide a pr # and shipping label to return the set for evaluation.Will you please provide the date the malfunction occurred and a description of the malfunction? additional information on 05feb2024: we have the lot #(10)23105097.Additional information: please provide the date of event.Jan 19th, 2024.2.Please provide the batch# number? lot #(10)23105097.3.Any physical sample available for investigation? i did save the packaging and tubing from one of the lines and just the tubing from the other incident.I believe laurie has them.4.Did the event directly, or indirectly involve a patient or user? no patients were affected but nursing was trying to administer medications and had to set up new tubing.5.Please confirm the number of occurrences.Two syringe lines were noted to have the issue.

• 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: 18728347
• Report Number: 9616066-2024-00251
• Device Sequence Number: 12349843
• Product Code: FPA
• UDI-Device Identifier: 10885403233906
• UDI-Public: (01)10885403233906
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/16/2024

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: 10/05/2026
• Device Catalogue Number: 10014914
• Device Lot Number: 23105097
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 02/17/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown