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 Code	Leak/Splash (1354)
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
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the 16 in non-dehp stnd bore extension set leaked.The following information was provided by the initial reporter: "i wanted to follow-up on the product report below, there was another filter leak with this same product reported today.".
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model mx9166, lot number 20025076, was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h.10.
Event or Problem Description
It was reported that the 16 in non-dehp stnd bore extension set leaked.The following information was provided by the initial reporter: "i wanted to follow-up on the product report below, there was another filter leak with this same product reported today.".

• 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: 10666674
• Report Number: 9616066-2020-20063
• Device Sequence Number: 3281655
• 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: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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 Expiration Date: 01/04/2025
• Device Model Number: MX9166
• Device Catalogue Number: MX9166
• Device Lot Number: 20025076
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/12/2020
• 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
• Outcome Attributed to Adverse Event: Other