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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SMARTSITE¿ EXTENSION SET INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SMARTSITE¿ EXTENSION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 20039E
Device Problems Complete Blockage (1094); Restricted Flow rate (1248)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: product was not available for investigation, however the customer indicates that the flow restriction was observed during priming. As part of the investigation, the customer provided a photograph of the affected sample connected to an unknown syringe; analysis of the photograph did not identify any obvious manufacturing defects which may have contributed to the customer's experience. The details of this feedback were forwarded to the manufacturing site for investigation. A review of the production records for the lot number provided did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature. A definitive root cause for the customer's experience could not be determined as the sample was not available for investigation. However, following a small number of similar reports, bd has conducted an in-depth investigation to identify any potential contributing factors for occlusion 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 of the smartsite 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. Please note, in order to minimize reports for occlusions of this nature, the manufacturing site has repaired the assembly machine to ensure that an adequate amount of fluorosilicone is injected into each smartsite. A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 20039e product in the past 12 months.
 
Event Description
It was reported two bd alaris¿ smartsite¿ extension sets had flow issues and were blocked. The following information was provided by the initial reporter: "can¿t priming easily with luer-lok syringe at beginning".
 
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Brand NameBD ALARIS¿ SMARTSITE¿ EXTENSION SET
Type of DeviceINTRAVASCULAR 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12675950
MDR Text Key277885617
Report Number9616066-2021-52285
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20039E
Device Catalogue Number20039E
Device Lot Number21065304
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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