MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD SMARTSITE 20MM VIAL ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2205E
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
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 smartsite 20mm vial access device had foreign matter.The following information was received by the initial reporter with the following verbatim.The following information was received by the initial reporter with the following verbatim.The nurse opened the package and found a yellow stain on the connector nut.
Additional Manufacturer Narrative
No samples were received for investigation of (b)(4), in which the customer has stated: "the nurse opened the package and found a yellow stain on the connector nut." the product in use at the time is reported to be a 2205e.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation; however, the given lot number is incorrect and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.In this instance, without the complaint sample to examine it has not been possible to conclusively link this feedback to a specific failure mode; however, a review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the 2205e products in the past 12 months.
Event or Problem Description
No additional information.

• Brand Name: BD SMARTSITE 20MM VIAL ACCESS DEVICE
• 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: 21172664
• Report Number: 9616066-2024-02275
• Device Sequence Number: 9412845
• Product Code: FPA
• UDI-Device Identifier: 07613203011778
• UDI-Public: (01)07613203011778(10)24025030
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K233021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: 2205E
• Device Lot Number: 24025030
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown