MAUDE Adverse Event Report: CAREFUSION ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	30893-07
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
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.Additional information requested, but was not provided.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "the epidural tubing was leaking from the purple port end on multiple sets of tubing.Four were found to be faulty.The doctor was upset because this poses an infection risk for patient not having a closed system, which can enter the epidural space." an incomplete date of event of (b)(6) 2019 was provided.
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint of a tubing leak could not be confirmed due to the product was not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "the epidural tubing was leaking from the purple port end on multiple sets of tubing.Four were found to be faulty.The doctor was upset because this poses an infection risk for patient not having a closed system, which can enter the epidural space." an incomplete date of event of (b)(6) 2019 was provided.

• Brand Name: ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9481135
• Report Number: 9616066-2019-03615
• Device Sequence Number: 18896790
• Product Code: FPA
• UDI-Device Identifier: 10885403460234
• UDI-Public: 10885403460234
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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: 02/06/2022
• Device Model Number: 30893-07
• Device Catalogue Number: 30893-07
• Device Lot Number: 19025228
• 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: 12/17/2019
• Supplement Report FDA Received Date: 02/26/2020
• 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: THERAPY DATE: UNKNOWN