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

Device Problems Complete Blockage (1094); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2020

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11088955
• MDR Text Key: 250329045
• Report Number: 9616066-2020-20667
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403235373
• UDI-Public: 50885403235373
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1