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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 36 IN 15 DROP SECONDARY SET W/HGR INTRAVASCULAR ADMINISTRATION SET

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36 IN 15 DROP SECONDARY SET W/HGR INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MS3500-15
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/02/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that 36 in 15 drop secondary set w/hgr contained foreign matter. The following information was provided by the initial reporter: "spike was dirty in closed packaging. Went to spike a bag and found a dark brown/red particle. ".
 
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Brand Name36 IN 15 DROP SECONDARY SET W/HGR
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
MDR Report Key12453564
MDR Text Key270836167
Report Number9616066-2021-52004
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K790582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 08/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS3500-15
Device Catalogue NumberMS3500-15
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
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

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