MAUDE Adverse Event Report: CAREFUSION EXT T CONN W/SPIN LOCK SPLIT SEPTUM SM; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	21001M-07
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported the t-connector extension set cracked and/or disconnected from the central venus line (cvl) during patient use.There was no report of patient harm.

• Brand Name: EXT T CONN W/SPIN LOCK SPLIT SEPTUM SM
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7830763
• Report Number: 9616066-2018-01509
• Device Sequence Number: 11374437
• Product Code: FPA
• UDI-Device Identifier: 10885403222832
• UDI-Public: 10885403222832
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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
• Report Date (Section B): 08/09/2018

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: 21001M-07
• Device Catalogue Number: 21001M-07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1