MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET SMALLBORE TBG W/SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10011253
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	10/22/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the ext set smallbore tbg w/ss dehp free was clogged/blocked/occluded.The following information was provided by the initial reporter: material no: 10011253, batch no: 20056551.The new sets that have been deployed as a sub for item 20039e] are having the same issue where you cannot push fluids through the extension set.I have had multiple complaints within the last week that this issue is still occurring.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.It was reported that the facility is having issues pushing fluids through the extension 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 10011253 lot number 20056551 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - fluid blockage with lot #20056551 regarding item #10011253.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 the ext set smallbore tbg w/ss dehp free was clogged/blocked/occluded.The following information was provided by the initial reporter: material no: 10011253 batch no: 20056551.The new sets that have been deployed as a sub for item 20039e] are having the same issue where you cannot push fluids through the extension set.I have had multiple complaints within the last week that this issue is still occurring.

• Brand Name: EXT SET SMALLBORE TBG W/SS DEHP FREE
• 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: 10856481
• Report Number: 9616066-2020-20354
• Device Sequence Number: 14071023
• Product Code: FPA
• UDI-Device Identifier: 10885403233609
• UDI-Public: 10885403233609
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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,Followup
• Report Date (Section B): 11/24/2020

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 Expiration Date: 05/23/2023
• Device Catalogue Number: 10011253
• Device Lot Number: 20056551
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1