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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION
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CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION Back to Search Results
Catalog Number 4C8723
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Device manufacturer address: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a hair was found in the drip chamber of a clearlink system y-type blood/solution set.The issue was identified during unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed on the photograph using the naked eye which observed a hair in the filter.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
CLEARLINK BLOOD RECIPIENT SET
Type of Device
SET, BLOOD TRANSFUSION
MDR Report Key12542685
MDR Text Key273658032
Report Number1416980-2021-05976
Device Sequence Number1
Product Code BRZ
Combination Product (y/n)Y
PMA/PMN Number
K993120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4C8723
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received10/29/2021
Was Device Evaluated by Manufacturer? No
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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