MAUDE Adverse Event Report: CAREFUSION MICROBORE QUAD-FUSE EXTENSION SET, 4 IV; SET, EXTENSION, INTRAVASCULAR

Model Number	MZ9275
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that when checking the patient iv lines a crack was noted at the luer connector.The nurse attempted to disconnect the extension set however it cracked further and was difficult to remove.There was no report patient harm.The event occurred nicu.
Additional Manufacturer Narrative
Baby boy the customer¿s report of a cracked luer connector was confirmed.Visual inspection of the set identified a crack in the male luer.Closer inspection under a lab microscope observed no stress marks or tool marks.Due to the broken male luer collar, functional tests could not be performed.The root cause of the male luer crack was not determined.
Event or Problem Description
The customer reported that when checking the patient iv lines a crack was noted at the luer connector.The nurse attempted to disconnect the extension set however it cracked further and was difficult to remove.There was no report patient harm.The event occurred nicu.

• Brand Name: MICROBORE QUAD-FUSE EXTENSION SET, 4 IV
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8075559
• Report Number: 9616066-2018-02200
• Device Sequence Number: 16685777
• Product Code: FPA
• UDI-Device Identifier: 10885403240768
• UDI-Public: 10885403240768
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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 Expiration Date: 08/21/2021
• Device Model Number: MZ9275
• Device Catalogue Number: MZ9275
• Device Lot Number: 18086556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 02/06/2019
• 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: PRI TUBING, THERAPY DATE (B)(6) 2018
• Patient Age: 4 DA