MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SMARTSITE DUAL-PORT EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	30207E
Medical Device Problem Codes	Defective Component (2292); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
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 was damaged.The following information was received by the initial reporter with the following verbatim 2 faulty ones - the bung is up-side down.
Additional Manufacturer Narrative
A 30207e sample was not required for investigation of this feedback as the customer provided a photograph of the affected sample.The customer reported that the affected sample was from lot 24079464 and "2 faulty ones - the bung is up-side down".Analysis of the photograph confirmed the customer's experience with the smartsite y-site identified to have been assembled upside down.The details of this feedback were forwarded to the manufacturing site for investigation.Their analysis confirmed that the misassembly is most likely to have been caused by the human error during the manual assembly process, which was then not identified during subsequent assembly steps.A review of the production records for lot 24079464 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In order to reduce the likelihood of operator error, the production personnel have been informed of this feedback to ensure that they are following the correct assembly process.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 30207e product over the past 12 months.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS SMARTSITE DUAL-PORT EXTENSION 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: 21055338
• Report Number: 9616066-2024-02158
• Device Sequence Number: 8068099
• Product Code: FPA
• UDI-Device Identifier: 07613203011495
• UDI-Public: (01)07613203011495
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: 30207E
• Device Lot Number: 24079464
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown