MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET, IV CONNECTOR, T; SET, EXTENSION, INTRAVASCULAR

Model Number	MZXT9001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported fluid leaked from the t-connector extension set when attached to the patient's picc line and flushed.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report of a leaking t-connector was confirmed.Visual inspection of the set showed no damage or any anomalies.Examination under magnification revealed a thin crack spanning the length of the female luer body.Functional testing confirmed leaking at the attachment of the valve to the female luer.The cause of the leak was determined to be a cracked female luer body.The root cause of the crack was not determined.
Event or Problem Description
The customer reported fluid leaked from the t-connector extension set when attached to the patient's picc line and flushed.There was no report of patient harm.

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR, T
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7852896
• Report Number: 9616066-2018-01562
• Device Sequence Number: 11259303
• Product Code: FPA
• UDI-Device Identifier: 10885403240805
• UDI-Public: 10885403240805
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2018

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
• Operator of Device: Health Professional
• Device Model Number: MZXT9001
• Device Catalogue Number: MZXT9001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PICC LINE, FLUSH SYRINGE, THERAPY DATE UNK; PICC LINE, FLUSH SYRINGE, THERAPY DATE UNK