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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 LOW SORBING EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE LOW SORBING EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 20350E
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2023
Event Type  malfunction  
Event Description
It was reported while using bd alaris smartsite low sorbing extension set the tubing was kinked and there was discoloration.There was no report of patient impact.The following information was provided by the initial reporter: tubing kinked and discolored.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 07-feb-2023.H6: investigation summary: thirty three samples were received for quality evaluation.The customer complaint of tubing kinked was verified by inspection.The thirty three samples were initially visually inspected for kinks throughout the tubing assemblies.Four samples of the thirty-three samples submitted showed signs of kinking in the tubing.Further examination of the samples show that the kinks are located on the tubing close to the connection ports of the in-line filters.The samples were connected to a syringe and fluid was pushed through each of the samples with kinks in the tubing.The extension sets did not slow down the affect the ability for fluid to flow through each of the samples.The customer complaint of cosmetic issues was not verified by visual inspection.There was no evidence of discolored components or tubing in the samples received.A device history record review for model 20350e lot number 22099098 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing location has been made aware of the failure and further investigation was conducted to determine the root cause of the kinking.During the investigation it was determined that excess solvent was observed when attempting to replicate the failure.Additionally, the equipment used to expand the tubing had an issue with the tube expander causing the tubing to not be inserted into to sleeve correctly, leaving gaps in the construction, allowing for kinking to occur.A quality alert was generated to prevent this defect and updates to the assembly process have been implemented to correct the issue for future production.A root cause for the customer complaint of cosmetic issue could not be determined because the failure mode could not be verified.
 
Event Description
It was reported while using bd alaris smartsite low sorbing extension set the tubing was kinked and there was discoloration.There was no report of patient impact.The following information was provided by the initial reporter: tubing kinked and discolored.
 
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Brand Name
BD ALARIS SMARTSITE LOW SORBING EXTENSION SET
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16394025
MDR Text Key310100846
Report Number3014704491-2023-00016
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203012264
UDI-Public(01)37613203012264
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number20350E
Device Catalogue Number20350E
Device Lot Number22099098
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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