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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,INTRVASCULAR
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CAREFUSION MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR; SET,ADMINISTRATION,INTRVASCULAR Back to Search Results
Model Number MZ5307
Device Problems Break (1069); Failure to Disconnect (2541); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2018
Event Type  malfunction  
Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
The customer reported on9wt hematology/oncology , a rn was heparin locking a patient who was to be discharged home, and they were unable to disconnect the bifuse from the white lumen.The "luerlock" end of the bifuse was stripped and the hub was not able to be turned in order to dislodge from the cap.The end of the product broke off into the cap and the rn had to compete a cap change early, even though it had just been changed the day prior.There was no patient harm.
 
Event Description
The customer reported on9wt hematology/oncology, a rn was heparin locking a patient who was to be discharged home, and they were unable to disconnect the bifuse from the white lumen.The "luerlock" end of the bifuse was stripped and the hub was not able to be turned in order to dislodge from the cap.The end of the product broke off into the cap and the rn had to compete a cap change early, even though it had just been changed the day prior.There was no patient harm.
 
Manufacturer Narrative
The customer¿s report of an inability to disconnect the bifuse from the white lumen was not confirmed.The customer¿s report that the product broke and was stripped was confirmed.Visual inspection showed that the male spin collar on the extension set had a crack running parallel to the direction of the flow.Further inspection of the damaged component under magnification showed that the ridges on the male luer were stripped.The maxzero valve that was connected to the extension set was successfully disconnected from the extension set.The root cause of the product breakage is excessive force being applied to the product when attempting to disconnect and/or over-tightening when the mating components were connected.
 
Event Description
The customer reported on9wt hematology/oncology , a rn was heparin locking a patient who was to be discharged home, and they were unable to disconnect the bifuse from the white lumen.The "luerlock" end of the bifuse was stripped and the hub was not able to be turned in order to dislodge from the cap.The end of the product broke off into the cap and the rn had to compete a cap change early, even though it had just been changed the day prior.There was no patient harm.
 
Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
 
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Brand Name
MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR
Type of Device
SET,ADMINISTRATION,INTRVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key7904341
MDR Text Key121562791
Report Number9616066-2018-01796
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 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2018
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 Manufacturer09/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MZ1000-07, TD (B)(6) 2018; MZ5307, TD (B)(6) 2018
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