MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMALLBORE 6 INCH EXT VLV; INTRAVASCULAR ADMINISTRATION SET

Model Number 20039E

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the smallbore 6 inch ext vlv had flow issues while attempting to flush it.The following information was provided by the initial reporter: "item # 20039e having issues flushing through the set.".

Manufacturer Narrative

Investigation summary: no product or photo was returned by the customer.It was reported that there are issues with flushing through the set.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 20039e lot number 20076800 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 21jul2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that the smallbore 6 inch ext vlv had flow issues while attempting to flush it.The following information was provided by the initial reporter: "item # 20039e having issues flushing through the set.".

• Brand Name: SMALLBORE 6 INCH EXT VLV
• Type of Device: 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: 11084320
• MDR Text Key: 245042701
• Report Number: 9616066-2020-20657
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 27613203013820
• UDI-Public: 27613203013820
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

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
• Device Operator: Other
• Device Expiration Date: 07/20/2023
• Device Model Number: 20039E
• Device Catalogue Number: 20039E
• Device Lot Number: 20076800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1