MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET, SS Y, CHECK VALVE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	30842E
Medical Device Problem Codes	Leak/Splash (1354); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the ext set, ss y, check valve experienced leakage and tubing expansion/ballooning.The following information was provided by the initial reporter: number of affected samples unknown, customer has 12 boxes (1200 eaches).Customer submitting internal incident report to clinical product managers, awaiting more details.As per phone message only a few incidents however customer has decided to pull all stock out of clinical use pending investigation.
Additional Manufacturer Narrative
H6: investigation summary: a 30842e-0006 sample was not available for investigation of this feedback.However the customer indicates that leakage and swelling of the smartsite component was identified.Further information regarding the nature of the event was not available to assist the investigation.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined in this instance.Without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported issue.In this instance, without the complaint sample or additional information about the exact nature of the defect it is not possible to conclusively link this feedback to a specific failure mode.H3 other text : see h.10.
Event or Problem Description
It was reported that the ext set, ss y, check valve experienced leakage and tubing expansion/ballooning.The following information was provided by the initial reporter: number of affected samples unknown, customer has 12 boxes (1200 eaches).Customer submitting internal incident report to clinical product managers, awaiting more details.As per phone message only a few incidents however customer has decided to pull all stock out of clinical use pending investigation.

• Brand Name: EXT SET, SS Y, CHECK VALVE
• 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: 11070162
• Report Number: 9616066-2020-20652
• Device Sequence Number: 14254672
• Product Code: FPA
• UDI-Device Identifier: 07613203023450
• UDI-Public: 07613203023450
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 30842E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1