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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET, IV CONNECTOR,.F; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION MICROBORE EXTENSION SET, IV CONNECTOR,.F; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ9226
Device Problem Fluid/Blood Leak (1250)
Patient Problems No Information (3190); No Code Available (3191)
Event Date 10/20/2019
Event Type  malfunction  
Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Although requested, patient information was not provided.
 
Event Description
It was reported that a leak was found at the filter during infusion of an unspecified medication.It was also reported that the patient sustained "slight injury", was then examined by a provider, and no further treatment was required as there was no additional clinical findings or changes was noted on the patient.The tubing was then replaced.Although requested, additional event details were not provided.
 
Manufacturer Narrative
Additional information provided; d.10, & h.6.(patient code).The customer¿s report of a filter leak was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted no damage or any anomalies.Functional testing confirmed small droplets leaking from the air vent of the micron filter.The root cause of the leak could not be determined.
 
Event Description
It was reported that a leak was found at the filter during infusion of an unspecified medication.It was also reported that the patient sustained "slight injury", was then examined by a provider, and no further treatment was required as there was no additional clinical findings or changes was noted on the patient.The tubing was then replaced.Although requested, additional event details were not provided.
 
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Brand Name
MICROBORE EXTENSION SET, IV CONNECTOR,.F
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9501329
MDR Text Key177015207
Report Number9616066-2019-03716
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403240621
UDI-Public10885403240621
Combination Product (y/n)N
PMA/PMN Number
K140831
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMZ9226
Device Catalogue NumberMZ9226
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/20/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
10ML SYRINGE, THERAPY DATE: (B)(6) 2019
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