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

Model Number	10794983
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Additional information requested, including patient's demographics, but was not provided.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "nurse went to hook patient up to intravenous tubing, when connecting tubing the cap of tubing fell off leaving intravenous tubing on patient bedside while cap was connected to patient still." there was no patient impact.An incomplete date of event of (b)(6) 2020 was provided.
Additional Manufacturer Narrative
Correction on initial report: b.5.Additional; information provided: g.3.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "nurse went to hook patient up to intravenous tubing, when connecting tubing the cap of tubing fell off leaving intravenous tubing on patient bedside while cap was connected to patient still." there was no patient impact.

• Brand Name: SMALLBORE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9756702
• Report Number: 9616066-2020-00504
• Device Sequence Number: 13919890
• Product Code: FPA
• UDI-Device Identifier: 10885403234293
• UDI-Public: 10885403234293
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: 04/12/2022
• Device Model Number: 10794983
• Device Catalogue Number: 10794983
• Device Lot Number: 19045977
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR