MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. DEHPFREE PRI GRAV SET 1 SS VLV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	41173E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.Device expiration date: unknown.Medical device lot #: an invalid lot # of 20046883 was provided by the initial reporter.Device manufacture date: unknown.(b)(4).Investigation summary: one sample was received for quality investigation.The customers complaint of a missing roller clamp was verified by visual inspection.In addition to the visual inspection, comparison of the sample to the material number build of material (bom), it was confirmed that the roller clamp should be included on this assembly.No further defects or damages observed.A device history record review for model 41173e lot number 20045883 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10apr2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this occurrence is an issue with the assembly at the manufacturing facility.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: one sample was received for quality investigation.The customers complaint of the roller clamp (p/n 12281061) was missing was verified by visual inspection.In addition to the visual inspection, comparison of the sample to the material number build of material (bom), it was confirmed that the roller clamp should be included on this assembly.No further defects or damages observed.The root cause of this occurrence is an issue with the assembly at the manufacturing facility.
Event or Problem Description
It was reported that the dehpfree pri grav set 1 ss vlv experienced a missing component.The following information was provided by the initial reporter: material no: 41173e, batch no: unknown, (reported 20046883).I have product # 41173e, lot # 20046883 gravity set with roller clamp, with no roller clamp.

• Brand Name: DEHPFREE PRI GRAV SET 1 SS VLV
• 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: 11024801
• Report Number: 9616066-2020-20584
• Device Sequence Number: 3478377
• Product Code: FPA
• UDI-Device Identifier: 07613203020893
• UDI-Public: 07613203020893
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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
• Report Date (Section B): 12/07/2020

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 Catalogue Number: 41173E
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1