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

Catalog Number	10010483
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module syringe adapter set was leaking.The following information was received by the initial reporter with the verbatim: reported issue: leaking and will not stay connected.Injuries or adverse event: no.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported by customer that leaking and will not stay connected.No product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model 10010483 lot number 22125363 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15dec2022.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 #: (b)(4) batch #: 22125363 it was reported by customer that leaking and will not stay connected.Verbatim: rcc received a complaint via email.Email(s) attached.Reported issue: leaking and will not stay connected.Are any samples available for return? yes item: 10010483 quantity affected: 38 cases serial/lot number: (b)(6) po : (b)(4) injuries or adverse event: no.
Event or Problem Description
No additional information was provided.Material #: 10010483, batch #: 22125363.It was reported by customer that leaking and will not stay connected.Verbatim: rcc received a complaint via email.Email(s) attached.Reported issue: leaking and will not stay connected.Are any samples available for return? yes.Item: 10010483.Quantity affected: 38 cases.Serial/lot number: (b)(6).Po : 4516628311.Injuries or adverse event: no.
Additional Manufacturer Narrative
It was reported by customer that leaking and will not stay connected.Twenty samples of material number 10010483 were received for quality evaluation.The samples were visibly examined for damages or abnormalities.There were no visible issues with the samples submitted.The samples were then connected to a syringe filled with water and the tubing sets were inserted into an alaris pumps for a simulated infusion to be conducted.The distal end male luer connector was also connected to a sample extension set for testing purposes.The simulated infusion was conducted at 125 ml/hr.There were no issues with leakage for the infusion set tubing or the connectors.The customer complaint of leakage could not be confirmed.A root cause was not established because the reported failure could not be replicated.A device history record review for model 10010483 lot number 22125363 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15dec2022.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.

• Brand Name: BD ALARIS PUMP MODULE SYRINGE ADAPTER 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: 18081297
• Report Number: 9616066-2023-02154
• Device Sequence Number: 12409934
• Product Code: FPA
• UDI-Device Identifier: 50885403232600
• UDI-Public: (01)50885403232600
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K934095
• 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): 02/28/2024

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: 12/15/2025
• Device Catalogue Number: 10010483
• Device Lot Number: 22125363
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 01/12/2024; 02/28/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 01/16/2024; 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown