MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. Y EXT W/VLV PORTS & 2 SLD CLP; INTRAVASCULAR ADMINISTRATION SET

Model Number	20019E
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20115022.Medical device expiration date: 2023-11-10.Device manufacture date: 2020-11-03.Medical device lot #: 20115015.Medical device expiration date: 2023-11-05.Device manufacture date: 2020-11-03.Medical device lot #: 20095134.Device manufacture date: 2020-08-26.Medical device lot #: 20045839.Medical device expiration date: 2023-04-14.Device manufacture date: 2020-04-08.Investigation summary: six samples were returned for investigation.Samples were visually inspected for defects and abnormalities.No defects and abnormalities were observed.Samples were attached to a bd syringe and attempted to flush solution through the set.All samples were successfully primed.The customer complaint that the set will not flush was unable to be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 20019e lot number 20115015 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07nov2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 20019e lot number 20095134 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 18sep2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 20019e lot number 20115022 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 11sep2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 20019e lot number 20045839 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 17apr2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A trend for this occlusion issue has been identified for this product line.A capa (corrective action preventative action) has been initiated, and a team has been assembled in order to investigate the issue.(b)(4).
Event or Problem Description
It was reported that 6 y ext w/vlv ports & 2 sld clp clogged during use.The following was reported by the initial rerporter: "it was reported the set will not flush.Verbatim: same ongoing issue with this set; one leg will not flush.Hospital has six sets to return.Failure dates reported as "collected over the past few weeks." no patient harm as the failure was found during priming.Please do not contact anyone at (b)(6).".

• Brand Name: Y EXT W/VLV PORTS & 2 SLD CLP
• 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: 11285829
• Report Number: 9616066-2021-50175
• Device Sequence Number: 14382859
• Product Code: FPA
• UDI-Device Identifier: 27613203013813
• UDI-Public: 27613203013813
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2021

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: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: 20019E
• Device Catalogue Number: 20019E
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1