MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD SMARTSITE ADD-ON BAG ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10013365
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
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 add-on bag access device was damaged the following information was received by the initial reporter with the verbatim: eumdr/ smartsite bag access device dv failures - 1 sample sku 10013365-0006 failed iso-8536 50 kpa air leak testing.Subsequent leak testing confirmed that the leaking originated from the spike hub and spike port, more specifically where the spike hub wall meets the spike port.
Additional Manufacturer Narrative
Test sample 37 of sku 10013365-0006 failed iso-8536 50 kpa air leak testing.Subsequent leak testing confirmed that the leaking originated from the spike hub and spike port, more specifically where the spike hub wall meets the spike port.1/59 samples failed, doubled sampling plan and no additional failures noted.Defective sample sent to tj for investigation.Defect record awaiting qn # or investigation # for traceability.Device history record review for model 10013365-0006 lot number 22085920 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 31aug2022.Qn #200352045: eumdr leak defect record - this was created in response to this complaint and the r&d testing done by internal bd sources.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SMARTSITE ADD-ON BAG 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: 18655299
• Report Number: 9616066-2024-00195
• Device Sequence Number: 20629843
• Product Code: FPA
• UDI-Device Identifier: 27613203013912
• UDI-Public: (01)27613203013912
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K970485
• 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): 03/15/2024

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 Catalogue Number: 10013365
• Device Lot Number: 22085920
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown