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	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
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 the bd smartsite 20mm vial access device had package open seal / sterility concerns.The following information was provided by the initial reporter: during kit assembly, an operator identified a sealed pouch of the vial access device, with a foreign brown particle inside and some small holes on the plastic pouch.Before use.
Additional Manufacturer Narrative
Investigation result: one 2205e sample was received in sealed packaging from lot 24115472 for investigation.The customer reported that "during kit assembly, an operator identified a sealed pouch of the vial access device, with a foreign brown particle inside and some small holes on the plastic pouch." visual inspection of the returned sample confirmed the customer's experience; the blister was intact and completely sealed, however two small pieces of cardboard could be seen inside of the packaging.Additionally multiple small perforations were also observed in the plastic of the packaging, close to the spike of the vial adaptor.The details of this feedback were forwarded to the manufacturing site for investigation.Their investigation confirmed the contamination was likely to be cardboard, which had inadvertently entered the cleanroom and fallen into the packaging during the packaging process.Additionally, the perforations identified in the packaging of the product were likely to have been caused by the spike puncturing the plastic of the packaging; no similar damage has been observed during manufacturing, indicating that the perforations were likely caused by an isolated manipulation of the product after it had been packaged.A review of the production records for lot 24115472 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this report and will continue to monitor the incoming feedback and remain vigilant to issues of this nature during future production.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports for products manufactured at this manufacturing site 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.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24058129
• Report Number: 9616066-2025-04171
• Device Sequence Number: 9856054
• Product Code: FPA
• UDI-Device Identifier: 07613203011778
• UDI-Public: (01)07613203011778(11)241126(17)271126(10)24115472
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K233021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: 24115472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown