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 Codes	Complete Blockage (1094); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that grav set 20dp v/nv w/ckv 3ss 104-in had flow issues and foreign matter.The following information was provided by the initial reporter: material #: 42493e, batch/ lot #: 20015396.It was reported that the gravity administration set is not dripping adequately and is discolored.Verbatim: we received lot# and the staff is saying it¿s not dripping adequately.I¿m not sure if that¿s actually the case, but the color on the tube piece, not the tubing is a darker color than other lots and they are concerned there¿s an issue with this lot.

• 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: 11088955
• Report Number: 9616066-2020-20667
• Device Sequence Number: 2849822
• Product Code: FPA
• UDI-Device Identifier: 50885403235373
• UDI-Public: 50885403235373
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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: 01/20/2023
• Device Model Number: 42493E
• Device Catalogue Number: 42493E
• Device Lot Number: 20015396
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1