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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 EXTENSION SET DEHP FREE; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EXTENSION SET DEHP FREE; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 10012866
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2022
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd extension set dehp free experienced blockage.The following information was provided by the initial reporter: i do not have packaging with the product, but i would assume that since this is a reoccurring issue, that it is most likely the same lot.
 
Manufacturer Narrative
H.6.Investigation summary: one sample model # 2420-0500, lot 22023008 and 1 sample model #10012866 ,lot 22029622(extension filter set) was returned for quality investigation by the customer.The sets were examined for defects and abnormalities.No drip camber came with model 2420-0050 and the tubing was tied together at the proximal end.Model 10012866 was connected to a 10 ml bd syringe filled with glycerin water but unable to be flushed.Then the ports on the filters were checked for solvent at the filter inlet and outlet by cutting the tubing and then using a pin gauge of 0.035 to check for solvent and solvent was not observed.The customer complaint that they have a reoccurring issue with product clogging at the filter was able to be replicated.The investigative findings as below : one sample was returned to pall newquay to aid the investigation.Initial review of the filter set showed no anomalies with the filter, the filter was observed to have had the tubing removed from both ports of the filter.The filter was then subjected to red dye being flowed through the filter to check for any blockages within the filter set.There were no blockages observed within the returned filter, the filter was then plugged and pressure was able to be held within the filter with no leakages observed.The filter was then tested for flow and the product was observed to pass the release specification for this product, 110ml was captured during the test for 1 minute (pass specification for this product is greater than 100ml gathered in one minute).The root cause of lipid clogged at the filter could not be definitively determined.No issue in the filter was observed.A device history record review for model #2420-0500 and lot number #22023008 was performed.The search showed that a total of 23,703 units in 1 lot number was built on (b)(6) 2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot # 22023008.A device history record review for model #10012866 and lot number #22029622 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot # 22029622.Conclusion: in conclusion, the reported occlusion could not be confirmed at pall newquay.Due to the occlusion not being observed at pall newquay there is no further actions deemed necessary on this occasion.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the bd extension set dehp free experienced blockage.The following information was provided by the initial reporter: i do not have packaging with the product, but i would assume that since this is a reoccurring issue, that it is most likely the same lot.
 
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Brand Name
BD EXTENSION SET DEHP FREE
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 Key15168251
MDR Text Key304968071
Report Number9616066-2022-01053
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403233777
UDI-Public10885403233777
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790108
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 10/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number10012866
Device Lot Number22029622
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BD ALARIS¿ PUMP MODULE SET
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