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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 MICROBORE SLIDE CLAMP; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EXTENSION SET MICROBORE SLIDE CLAMP; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number ME2020
Device Problems Complete Blockage (1094); Crack (1135); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2022
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.Device expiration date: unknown.Device manufacture date: unknown.
 
Event Description
It was reported that the bd extension set microbore slide clamp experienced blockage.The following information was provided by the initial reporter: nurse was priming sodium bicarb through syringe tubing, difficult to prime/flush, top of tubing cracked and medication splashed back into nurses face/eye.
 
Event Description
It was reported that the bd extension set microbore slide clamp experienced blockage.The following information was provided by the initial reporter: nurse was priming sodium bicarb through syringe tubing, difficult to prime/flush, top of tubing cracked and medication splashed back into nurses face/eye.
 
Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.It was reported that the "nurse was priming sodium bicarb through syringe tubing, difficult to prime/flush, top of tubing cracked and medication splashed back into nurses face/eye".The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model me2020 because a lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
 
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Brand Name
BD EXTENSION SET MICROBORE SLIDE CLAMP
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 Key15324242
MDR Text Key305365430
Report Number9616066-2022-01247
Device Sequence Number1
Product Code FPA
UDI-Device Identifier20885403236256
UDI-Public20885403236256
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051499
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 10/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberME2020
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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