MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D SS 0.2M CV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2434-0007
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: a complaint of cracks in the connection site was received from the customer.No product or photo was returned by the customer.The customer complaint of damaged adapter 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 2434-0007 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 as lvp 20d ss 0.2m cv was cracked.The following information was provided by the initial reporter: material no: 2434-0007, batch no: unknown.It was reported that there are cracks in the connection port of this item.
Additional Manufacturer Narrative
H6: investigation summary: a complaint of cracks in the connection site was received from the customer.No product or photo was returned by the customer.The customer complaint of damaged adapter 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 2434-0007 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h10.
Event or Problem Description
It was reported that as lvp 20d ss 0.2m cv was cracked.The following information was provided by the initial reporter: material no: 2434-0007 batch no: unknown/ it was reported that there are cracks in the connection port of this item.

• Brand Name: AS LVP 20D SS 0.2M CV
• 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: 11339291
• Report Number: 9616066-2021-50237
• Device Sequence Number: 2671878
• Product Code: FPA
• UDI-Device Identifier: 07613203019682
• UDI-Public: 07613203019682
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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 Catalogue Number: 2434-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1