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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD ALARIS¿ SMARTSITE¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET
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BD ALARIS¿ SMARTSITE¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 30262E
Medical Device Problem Codes Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/02/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of component damage - leak 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 30262e because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.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 or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set male luer was damaged and leaked during use.The following information was provided by the initial reporter: "male luer bent." "did you experience any adverse events? no, just leaking.".
 
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Brand Name
BD ALARIS¿ SMARTSITE¿ EXTENSION SET
Common Device Name
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12555454
Report Number9616066-2021-52144
Device Sequence Number4306625
Product Code FPA
UDI-Device Identifier37613203011489
UDI-Public37613203011489
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K960280
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model Number30262E
Device Catalogue Number30262E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/02/2021
Initial Report FDA Received Date09/30/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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