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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION NON-VENTED BLOOD SET

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CAREFUSION NON-VENTED BLOOD SET Back to Search Results
Model Number 2477-0007
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2018
Event Type  malfunction  
Manufacturer Narrative
The customer¿s report of an unspecified tubing issue was confirmed. Visual inspection of the set showed no signs of damage or abnormalities. Examination under magnification revealed a thin slit/tear in the tubing, in between the upper and lower fitments. Functional testing confirmed leaking from the silicone pump segment. The root cause was not determined.
 
Event Description
The customer submitted an administration set sample stating there was an unspecified issue with the tubing which the value analysis team was unable to discern. There was initially no report of patient involvement. , however the received set had pockets of viscous, cloudy fluid through the tubing which indicated the potential of having been used on a patient.
 
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Brand NameNON-VENTED BLOOD SET
Type of DeviceBLOOD SET
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8206343
MDR Text Key131718772
Report Number9616066-2018-02609
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K894842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/23/2021
Device Model Number2477-0007
Device Catalogue Number2477-0007
Device Lot Number18057875
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2018
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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