MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. ADMIN SET 20 DP, W/ FILTER Y SITE; INTRAVASCULAR ADMINISTRATION SET

Model Number	A2-80071-DF
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that admin set 20 dp, w/ filter y site leaked.The following information was provided by the initial reporter: material no: a2-80071-df batch no: 20036759.It was reported that an administration set model was leaking at the filter.
Event or Problem Description
It was reported that admin set 20 dp, w/ filter y site leaked.The following information was provided by the initial reporter: material no: a2-80071-df, batch no: 20036759.It was reported that an administration set model was leaking at the filter.
Additional Manufacturer Narrative
H.6.Investigation: it was reported a2-80071-df-admin set 20 dp, w/ filter y site-na, that an administration set model was leaking at the filter.Sample or photos were not provided by the customer, the leak failure mode could not be confirmed on the model a2-80071-df.A gemba walk was carried out to identify possible findings in the manufacturing process according to the operations flow of the model a2-80071-df.No opportunities were found in the production process for the model a2-80071-df after the gemba walk was performed and the potential root cause could not be determined since the failure mode was not confirmed.Also, the leak is reported in the filter, it is provided by the supplier, but tj manufacturing cannot guarantee that it is a supplier related failure mode because there are some factors that can lead to this failure mode (if is for a damage, raw material, badly sealed, handling in the process, etc.).To detect leak failure mode, the pcp personnel perform leak tests to the model produced according to the atp-007 tp, product leak tahiti-10000004835.Dhr review model : a2-80071-df, lot: 20036759, no qns were found in the reported lot.

• Brand Name: ADMIN SET 20 DP, W/ FILTER Y SITE
• 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: 10939506
• Report Number: 9616066-2020-20510
• Device Sequence Number: 2470031
• Product Code: FPA
• UDI-Device Identifier: 00814371020075
• UDI-Public: 00814371020075
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 12/22/2020

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: 03/22/2023
• Device Model Number: A2-80071-DF
• Device Catalogue Number: A2-80071-DF
• Device Lot Number: 20036759
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1