MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. TRI-PORT EXT SET W/LL DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number	10839681
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the tri-port ext set w/ll dehp free experienced device damage/deformation and leakage.The following information was provided by the initial reporter: material no.: 10839681 batch no.: unknown.Trifurcate attached to patient cracked and leaking, issue discovered when rn flushed port prior to starting platelet infusion.Crack noted on yellow portion of extension set (piece that connects to the microclave/cap, confirmed leaking at this point by disconnecting trifurcate from patient and flushing it again).

• Brand Name: TRI-PORT EXT SET W/LL DEHP FREE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 10840219
• Report Number: 9616066-2020-20336
• Device Sequence Number: 3006755
• Product Code: FPA
• UDI-Device Identifier: 50885403234536
• UDI-Public: 50885403234536
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2020

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: Other
• Device Model Number: 10839681
• Device Catalogue Number: 10839681
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1