MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 36 IN NON-DEHP MINIBORE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	ME1110
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown initial reporter phone#: (b)(6) (within medline) the customer's address is unknown.(b)(6) usa has been used as a default.Device manufacture date: unknown.(b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint of foreign matter - hair could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model me1110 because a lot number was not provided by the customer.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that 36 in non-dehp minibore extension set had foreign matter.The following information was provided by the initial reporter: material no: batch no: it was reported that there was a foreign contamination of a hair involving the extension set.
Additional Manufacturer Narrative
This complaint is not mdr reportable.Picture shows hair on packaging and outside of the device fluid path.There was no report of serious injury, medical intervention, or reportable device malfunction.
Event or Problem Description
It was reported that 36 in non-dehp minibore extension set had foreign matter.The following information was provided by the initial reporter: material no: batch no: it was reported that there was a foreign contamination of a hair involving the extension set.

• Brand Name: 36 IN NON-DEHP MINIBORE 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: 10744509
• Report Number: 9616066-2020-20200
• Device Sequence Number: 3569603
• Product Code: FPA
• UDI-Device Identifier: 50885403236042
• UDI-Public: 50885403236042
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: ME1110
• Device Catalogue Number: ME1110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1