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

Model Number	30893-07
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
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 not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the epidural tubing leaked which causes delay of treatment.There was no harm to patient.
Additional Manufacturer Narrative
Correction on initial report: b.4 & g.4.
Event or Problem Description
It was reported that the epidural tubing leaked which causes delay of treatment.Although requested, there has been no further patient or event information made available to date.
Event or Problem Description
It was reported that the epidural tubing leaked which causes delay of treatment.Although requested, there has been no further patient or event information made available to date.
Additional Manufacturer Narrative
Photo provided by the customer show (2) two pcea extension sets and three packaging pouches, with one of them being labeled ¿bad one¿ with no issues observed.The root cause of this failure was not identified.

• 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: 9412461
• Report Number: 9616066-2019-03555
• Device Sequence Number: 4130663
• Product Code: FPA
• UDI-Device Identifier: 10885403460234
• UDI-Public: 10885403460234
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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,Followup
• Report Date (Section B): 11/18/2019

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: 09/28/2020
• Device Model Number: 30893-07
• Device Catalogue Number: 30893-07
• Device Lot Number: 17096818
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 02/10/2020; 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR