MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SMARTSITE NEEDLE-FREE VALVE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2000E CHINA

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that bd alaris smartsite needle-free valve was occluded the following information was received by the initial reporter with the following verbatim: the head nurse reported that during use of the product, she found that the connector was blocked and the liquid could not be pushed in.The affected quantity is 5.Green claims are required, a complaint response letter is required, and a complaint acceptance letter is required.One sample can be returned, and photos can be provided.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: one 2000e china sample was received in opened packaging from lot 23085222.No sample of the products used to access the smartsites were provided to aid the investigation.The customer reported that "the connector was blocked and the liquid could not be pushed in." the returned sample was subjected to functional testing by priming and subjecting to an infusion using a 50ml bd plastipak syringe; the smartsite was identified to be occluded at first, however the occlusion released after disconnecting and reconnecting the syringe and no further flow issues were experienced.The details of this feedback were forwarded to the manufacturing site for investigation.Following a small number of similar reports, bd has conducted an in-depth investigation to identify any potential contributing factors for occlusion at the smartsite of this nature.The investigation has determined that a potential contributor could be the result of an insufficient amount of fluorosilicone having been injected into the piston during the assembly process; fluorosilicone is used as a lubricant within the smartsite to ensure the consistent opening of the piston when the smartsite is activated, and an insufficient amount may cause a temporary occlusion.They confirmed that at the start of the assembly process the manufacturing operative is required to measure whether a sufficient amount of flourosilicone is being injected into the smartsite.A review of the production records for lot 23085222 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Since the manufacture of the reported lot, improvements have been implemented to the fluorosilicone weighing procedure, with the implementation of a new fixture.Furthermore 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 reports of this nature against products in the 2000e china product family are rare and have been occurring at a low frequency within the last 12 months.

• Brand Name: BD ALARIS SMARTSITE NEEDLE-FREE VALVE
• Type of Device: 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: 18934185
• MDR Text Key: 338318549
• Report Number: 9616066-2024-00430
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203011938
• UDI-Public: (01)07613203011938
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2000E CHINA
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1