MAUDE Adverse Event Report: CAREFUSION STANDARDBORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MX4450
Medical Device Problem Codes	Disconnection (1171); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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
It was reported that when connecting manifold extension set to a pressure rated extension set it disconnected.The event occur in the cath lab.Although requested there are no additional details provided at this time.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "bd max zero -the tubing doesn't remain connected, but instead backs off the threaded piece." an incomplete date of event of (b)(6) 2019 was provided.Customer advocacy received a copy of the customer's medwatch report from the fda which states, "the tubing doesn't remain connected, but instead backs off the threaded piece." an incomplete date of event of (b)(6) 2019 was provided.
Additional Manufacturer Narrative
Additional medwatch information provided.The customer¿s report of a disconnection was not confirmed.Visual inspection of the set noted no damage or any anomalies.Functional testing resulted in the set priming successfully from every port and no leaks or disconnections were found throughout the sets.Pressure testing confirmed there were no signs of leaking or disconnecting anywhere on the returned set while the tubing was manipulated at each engagement.The sets female and male luer ports were measured and found to be within iso standards.The root cause of the customer¿s report was not identified.

• Brand Name: STANDARDBORE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8579912
• Report Number: 9616066-2019-01157
• Device Sequence Number: 19249052
• Product Code: FPA
• UDI-Device Identifier: 10885403274671
• UDI-Public: 10885403274671
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2023
• Device Model Number: MX4450
• Device Catalogue Number: MX4450
• Device Lot Number: 18115222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 07/19/2019
• 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: PRIMARY TUBING, THERAPY DATE UNK