MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 16 IN NON-DEHP STND BORE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MX9166
Medical Device Problem Codes	Leak/Splash (1354); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that 16 in non-dehp stnd bore extension set leaked causing underinfusion.The following information was provided by the initial reporter: material no: mx9166 batch no: unknown.It was reported that at conclusion of drug infusion and when disconnecting iv tubing, fluid was observed to be leaking from the filter onto the chair and onto the patient.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The root cause of this failure could not be identified without a failure investigation.A device history record review could not be performed on model mx9166 because a lot number was not provided by the customer.
Event or Problem Description
It was reported that 16 in non-dehp stnd bore extension set leaked causing underinfusion.The following information was provided by the initial reporter: material no: mx9166 batch no: unknown.It was reported that at conclusion of drug infusion and when disconnecting iv tubing, fluid was observed to be leaking from the filter onto the chair and onto the patient.

• Brand Name: 16 IN NON-DEHP STND BORE EXTENSION SET
• 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: 10722943
• Report Number: 9616066-2020-20182
• Device Sequence Number: 14299051
• Product Code: FPA
• UDI-Device Identifier: 50885403237650
• UDI-Public: 50885403237650
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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,Followup
• Report Date (Section B): 10/27/2020

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: MX9166
• Device Catalogue Number: MX9166
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1