MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. 10 INCH EXT W/ 0.2 PED & VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20029E
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a complaint of tubing becoming colored was received from the customer.No product or photo was returned by the customer.The customer complaint of discoloration could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 20029e because a lot number was not provided by the customer.Sterilization assurance in san diego stated that discoloration to the tubing and drip chamber material is a result of radiation sterilization.The light amber hue of the returned sets is considered to be a typical occurrence and is purely cosmetic; sterility and functionality are not affected.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: no product will be returned per customer.No investigation was performed.Root cause description: the root cause of this failure was not identified as no product was returned.
Event or Problem Description
It was reported that 6 10 inch ext w/ 0.2 ped & vlv ports experienced leakage, component separation, and foreign matter contamination.The following information was provided by the initial reporter: we have had 5 of the 0.2 micron filters #20029e.That have either started turning colors within the filter or cracked and leaking.
Event or Problem Description
It was reported that 6 10 inch ext w/ 0.2 ped & vlv ports experienced leakage, component separation, and foreign matter contamination.The following information was provided by the initial reporter: we have had 5 of the 0.2 micron filters #20029e.That have either started turning colors within the filter or cracked and leaking.
Additional Manufacturer Narrative
The following fields were updated due correction: b3: date of event: (b)(6) 2020.The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09/30/2020.Investigation conclusion: a complaint of tubing becoming colored, was received from the customer.5 samples were received for investigating.From visual inspection the discoloration can be seen; the customer complaint was verified.A device history record review could not be performed on model 20029e because a lot number was not provided by the customer.Sterilization assurance in san diego stated that discoloration to the tubing and drip chamber material is a result of radiation sterilization.The light amber hue of the returned sets is considered to be a typical occurrence and is purely cosmetic; sterility and functionality are not affected.A sterilization certificate could not be obtained due to no lot number being provided.A probable root cause for this failure was determined to be from the cracks on the filter.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Through visual inspection of the sample, discoloration of the filter could be seen.By looking under the microscope, a scratch can be seen going through the vent on the filter.When performing a leakage test with blue dye, some leaked out of the vent.Probable root cause for the discoloration was found to be related to the cracks in the filter near the vent.A sterilization certificate could not be obtained due to no lot number being provided.Priming with blue dye was performed to recreate what the customer did, and leakage at the vent could be seen.

• Brand Name: 10 INCH EXT W/ 0.2 PED & VLV PORT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10602948
• Report Number: 9616066-2020-02881
• Device Sequence Number: 3650343
• Product Code: FPA
• UDI-Device Identifier: 10885403234866
• UDI-Public: 10885403234866
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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: 20029E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other