MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GRAV SET 20DP V/NV W/CKV 3SS 104-IN; INTRAVASCULAR ADMINISTRATION SET

Model Number	42493E
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
Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint of tubing damaged / broken 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 42493e because a lot number was not provided by the customer.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.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 grav set 20dp v/nv w/ckv 3ss 104-in tubing was defective.The following information was provided by the initial reporter: material no: 42493e; batch no: unknown.It was reported that there was a recent issue with our iv tubing.
Event or Problem Description
It was reported that grav set 20dp v/nv w/ckv 3ss 104-in tubing was defective.The following information was provided by the initial reporter: material no: 42493e batch no: unknown it was reported that there was a recent issue with our iv tubing.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.A device history record review could not be performed on model 42493e because a 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.See h.10.

• Brand Name: GRAV SET 20DP V/NV W/CKV 3SS 104-IN
• 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: 10710182
• Report Number: 9616066-2020-20142
• Device Sequence Number: 3259613
• Product Code: FPA
• UDI-Device Identifier: 50885403235373
• UDI-Public: 50885403235373
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 10/21/2020

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 Model Number: 42493E
• Device Catalogue Number: 42493E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1