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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 LOW SORBING EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS LOW SORBING EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 24301-0007T
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2022
Event Type  malfunction  
Event Description
It was reported that the bd alaris low sorbing extension set had foreign matter on the filter 8 times.The following information was provided by the client: "the smooth side of the filter contains small black specks.Concern for contamination.Attempted to clean the outside of the tubing with an alcohol wipe but did not remove specks.(#8 total infusion sets found with specks)".
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, 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: 2022-03-07.H6: investigation summary: seven samples were received for quality investigation.The customer complaint of foreign matter was verified by visual inspection.Examination of the samples received indicate small pieces of foreign matter visible on the smooth side of the filter component.Further investigation of the filter component under magnification shows that the small pieces of foreign matter to be on the filter media or within the polymer housing of the filter.A device history record review for model 24301-0007t lot number 21105034 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 02oct2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of the issue is that the foreign matter was introduced during the construction of the filter component.Based on the investigation finding that the foreign matter exists inside of the filter and the infusion sets were not used prior to the investigation, the root cause can only be traced to the manufacturing of the filter component.
 
Event Description
It was reported that the bd alaris low sorbing extension set had foreign matter on the filter 8 times.The following information was provided by the client: "the smooth side of the filter contains small black specks.Concern for contamination.Attempted to clean the outside of the tubing with an alcohol wipe but did not remove specks.(#8 total infusion sets found with specks)".
 
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Brand Name
BD ALARIS 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 Key13773844
MDR Text Key287261277
Report Number9616066-2022-00238
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50885403223196
UDI-Public0150885403223196
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/10/2024
Device Catalogue Number24301-0007T
Device Lot Number21105034
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2021
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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