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 Code	Leak/Splash (1354)
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: no product or photo was returned by the customer.The customer complaint of the filter cracked and leaked could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model or lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.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: 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 6 10 inch ext w/ 0.2 ped & vlv port experienced damage/deformation and leakage.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
Supplemental mdr correction: b3: date of event on (b)(6) 2020.
Event or Problem Description
It was reported that 6 10 inch ext w / 0.2 ped & vlv port experienced damage / deformation and leakage.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 port experienced damage/deformation and leakage.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 to additional information: concomitant medical products: device available for eval yes.Concomitant products: returned to manufacturer on: 09/30/2020.Evaluation method codes: 10.Evaluation result codes:114.Evaluation conclusion codes: 133.Investigation conclusion a complaint of tubing leakage was received from the customer.5 samples were received for investigating.Visual inspection and leakage testing was performed to verify the customer complaint of cracked filters.A device history record review could not be performed on model 20029e because a lot number was not provided by the customer.Probable identified cause for vent leakage is clog/oversaturation of filter and time of use from which the fluid flow was restricted.Fluid then seeks path of least resistance through filter vent.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 10601914
• Report Number: 9616066-2020-02882
• Device Sequence Number: 3650342
• 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,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; Not provided
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/22/2020; 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