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

Catalog Number	42490E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
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 alaris smartsite gravity set was occluded.The following information was received by the initial reporter with the following verbatim: i have 3 complaints with regards to the gravity feed reference: (b)(4).I have one unit that is leaking at one of the port sites, this one i have with me.I also have a line with no packaging that has one of the needle free valves that has been inserted into the line that is upside down.This one i have with me as well.There were 2 other units that we had that had two ports that were closed and would not allow the needle free valves to work.They are from the same batch but unfortunately these two were disposed of by theater staff.
Additional Manufacturer Narrative
Investigation results: no 42490e sample was returned for investigation of this feedback, however the customer confirmed that the affected samples were from lot 23029234.The customer reported that on two occasions they experienced occlusion of flow from the smartsite.No further information or photographs were available to aid the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 23029234 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported occlusion.Please note, previous complaints for occlusions have been related to features on the surface of the male luer of the connecting products.These features include flash or a raised edge to the tip of the male luer which have previously been shown to intermittently lead to restricted flow due to them pinching the blue piston of the smartsite® and not allowing it to open.This can sometimes be resolved by disconnecting and reattaching the same luer connection which may reposition the luer against the piston and improve the flow, or alternatively by changing the connecting male luer.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 42490e product in the past 12 months.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS SMARTSITE GRAVITY 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: 18426804
• Report Number: 9616066-2023-02460
• Device Sequence Number: 8089223
• Product Code: FPA
• UDI-Device Identifier: 37613203010901
• UDI-Public: (01)37613203010901
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K820278
• 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): 03/06/2024

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 Expiration Date: 02/14/2026
• Device Catalogue Number: 42490E
• Device Lot Number: 23029234
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown