MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 105"ADMIN SET 20DP W/FILTER 2YSITES CLMP; INTRAVASCULAR ADMINISTRATION SET

Model Number	B2-70072-F
Medical Device Problem Code	Fungus in Device Environment (2316)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/25/2019
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 mold was found on the outside of 50 105"admin set 20dp w/filter 2ysites clmp packaging units.The following information was provided by the initial reporter: "an administration set model b2-70072-f lot 17055890 were 6 months outside of the expiration date some were showing mold on the outside of the packaging.Operator n/a.Medication none.No patient involved.Patient not harmed.(b)(6) 2019.".
Event or Problem Description
It was reported that mold was found on the outside of 50 105"admin set 20dp w/filter 2ysites clmp packaging units.The following information was provided by the initial reporter: "an administration set model b2-70072-f lot 17055890 were 6 months outside of the expiration date some were showing mold on the outside of the packaging.Operator n/a.Medication none.No patient involved.Patient not harmed (b)(6) 2019.".
Additional Manufacturer Narrative
H6: investigation summary: sample or photos were not provided by the customer, the contamination failure mode could not be confirmed on the model b2-70072-f.Root cause could not be determined since the failure mode was not confirmed (contamination - mold on the outside of the package).A device history review was conducted for lot number 17055890 no qns were found in the reported lot.

• Brand Name: 105"ADMIN SET 20DP W/FILTER 2YSITES CLMP
• 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: 10939461
• Report Number: 9616066-2020-20512
• Device Sequence Number: 4295335
• Product Code: FPA
• UDI-Device Identifier: 00814371020204
• UDI-Public: 00814371020204
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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 Expiration Date: 05/09/2020
• Device Model Number: B2-70072-F
• Device Catalogue Number: B2-70072-F
• Device Lot Number: 17055890
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1