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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ5307
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/30/2018
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
The customer reported on 9 wt hematology/oncology, a rn was told by the patient's mother that the patient's femoral cvc came off.The rn assessed the tubing, which had broken at the y-site.The rn cleaned the cvc and heparinized the line.There was no patient harm.
 
Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
The customer reported on 9 wt hematology/oncology, a rn was told by the patient's mother that the patient's femoral cvc came off.The rn assessed the tubing, which had broken at the y-site.The rn cleaned the cvc and heparinized the line.There was no patient harm.
 
Manufacturer Narrative
The customer¿s report that the line broke at the y-site was confirmed.Visual inspection of the set showed a separation at the engagement between the exit port of the bifuse adapter and the smallbore tubing.Examination under magnification showed evidence of only slight solvent.There were no other anomalies observed.Functional testing was deemed unnecessary due to the obvious separation.The root cause of the separation was insufficient solvent being applied at the engagement of the tubing.
 
Event Description
The customer reported on 9 wt hematology/oncology that the rn was told by the patient's mother that the patient's femoral cvc came off.The rn assessed the tubing, which had broken at the y-site.The rn cleaned the cvc and heparinized the line.There was no patient harm.
 
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Brand Name
MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key7827577
MDR Text Key118757444
Report Number9616066-2018-01474
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403230608
UDI-Public10885403230608
Combination Product (y/n)N
PMA/PMN Number
K140831
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 08/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMZ5307
Device Catalogue NumberMZ5307
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FEMORAL CVC, THERAPY DATE (B)(6) 2018
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