Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 DEHP 2SS CV; 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 DEHP 2SS CV; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2420-0500
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that a small hole in the as lvp 20d dehp 2ss cv line caused ns to "spray out".This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "on two separate occasions a new primary iv line was removed from the package and primed with ns.There was a pin point hole in the line that started spraying out.".
 
Event Description
It was reported that a small hole in the as lvp 20d dehp 2ss cv line caused ns to "spray out".This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "on two separate occasions a new primary iv line was removed from the package and primed with ns.There was a pin point hole in the line that started spraying out.".
 
Manufacturer Narrative
Investigation summary: due to no photo or sample being received, the customer's complaint of leakage could not be verified.A device history record review for model: 2420-0500, lot number: 20103006 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 06oct2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, the root cause remains unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AS LVP 20D DEHP 2SS CV
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
MDR Report Key11101602
MDR Text Key246120234
Report Number9616066-2020-20699
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203012448
UDI-Public37613203012448
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/06/2023
Device Model Number2420-0500
Device Catalogue Number2420-0500
Device Lot Number20103006
Was Device Available for Evaluation? No
Date Manufacturer Received12/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-