MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20 INCH EXT W/1 VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Model Number	30202E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fda device problem code: 1354.Fda patient problem code: 2199.Investigation summary: a device history record review for model 30202e lot number 20026464 was performed.The search showed that a total of 17,603 units in 1 lot number was built on 24feb2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Investigation conclusion: due to no photo or sample being received, the customer's complaint of leakage could not be verified.Root cause description: due to no sample being received, an investigation could not be performed and a root cause could not be determined.Rationale: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the 20 inch ext w/1 vlv port leaked chemo during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "i wanted to bring to your attention that when we were using the tubing substitution for chemo a few weeks ago we had a failure and had a major chemo spill.No one was harmed but the products were 26603-b007t and the extension set 30202e.Chemo leaked between the pump infusion set and the extension set." "the chemo spill occurred on september 28th, 2020 in our infusion center.What had happened was a nurse had administered the chemo to the patient.When she came back to check on the patient she noticed drug was leaking from where the pump infusion set was connected to the smartsite extension set.The line was clamped off appropriately and no chemo actually spilled onto the patient just on the floor.We followed our protocol to clean up a hazardous drug spill and no harm was done to the patient.The product numbers are 22603-b007t for the infusion set with lot# (10)20086389 and 30202e for extension set lot # (10)20026464.".
Additional Manufacturer Narrative
H.6.Investigation: due to no photo or sample being received, the customer's complaint of leakage could not be verified.A device history record review for model 30202e lot number 20026464 was performed.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.H3 other text : see h.10.
Event or Problem Description
It was reported that the 20 inch ext w/1 vlv port leaked chemo during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "i wanted to bring to your attention that when we were using the tubing substitution for chemo a few weeks ago we had a failure and had a major chemo spill.No one was harmed but the products were 26603-b007t and the extension set 30202e.Chemo leaked between the pump infusion set and the extension set." "the chemo spill occurred on (b)(6) 2020 in our infusion center.What had happened was a nurse had administered the chemo to the patient.When she came back to check on the patient she noticed drug was leaking from where the pump infusion set was connected to the smartsite extension set.The line was clamped off appropriately and no chemo actually spilled onto the patient just on the floor.We followed our protocol to clean up a hazardous drug spill and no harm was done to the patient.The product numbers are 22603-b007t for the infusion set with lot# (10)20086389 and 30202e for extension set lot # (10)20026464.".

• Brand Name: 20 INCH EXT W/1 VLV PORT
• 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: 10795819
• Report Number: 9616066-2020-20268
• Device Sequence Number: 4111851
• Product Code: FPA
• UDI-Device Identifier: 37613203011540
• UDI-Public: 37613203011540
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: Health Professional
• Device Expiration Date: 02/24/2023
• Device Model Number: 30202E
• Device Catalogue Number: 30202E
• Device Lot Number: 20026464
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1