• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D LOW SORB INTRAVASCULAR ADMINISTRATION SET

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D LOW SORB INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2260-0500
Device Problems Fluid Leak (1250); Insufficient Information (3190); Material Split, Cut or Torn (4008)
Patient Problem Chemical Exposure (2570)
Event Date 07/19/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. Medical device expiration date: unknown device manufacture date: unknown investigation summary: the customer reported an issue of leakage with bd infusion set of material 2260-0500. This complaint was captured using information provided by health canada¿s medical devices online databases. No photos or samples were provided and without further information. A device history record review could not be performed 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: the complaint cannot be verified and the root cause of this failure remains unknown.
 
Event Description
It was reported that as lvp 20d low sorb leaked. The following information was provided by the initial reporter: material split, cut or torn and fluid leak.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAS LVP 20D LOW SORB
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12330485
MDR Text Key266846233
Report Number9616066-2021-51805
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K931173
Number of Events Reported1
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 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2260-0500
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/17/2021 Patient Sequence Number: 1
-
-