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. BD ALARIS¿ SECONDARY SET; 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. BD ALARIS¿ SECONDARY SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 11448964
Device Problems Defective Component (2292); Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2022
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.
 
Event Description
It was reported that the bottom of the bd alaris¿ secondary set tubing was found open prior to use, and no luer lock was attached to the iv.The following information was provided by the initial reporter: "bottom of tubing is completely open, not leur lock to attach to a iv complaint noticed: prior to use".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 17-jan-2023.H6: investigation summary: a complaint of a set being assembled without a male luer was received.A sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.The set did not have a male luer.The tubing was inspected using a microscope and some traces of solvent could be seen.A device history record review for model 11448964 lot number 22089289 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 11aug2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect, and an investigation was performed.The manufacturing process was reviewed for potential root causes of this defect.The main root causes for missing component are material accumulation, distraction during operation and failure of the solvent dispenser with the probability that the component falls during the production process (by not being assembled correctly).However, sufficient solvent is observed in the tube, with no trace of component placement, and there are no blue keys generated for that batch.Therefore, the failure in the dispenser is rejected as a possible root cause.The accumulation of material and distraction during operation is accepted as a possible root cause.A quality alert was issued to all involved personnel to prevent this defect.
 
Event Description
It was reported that the bottom of the bd alaris¿ secondary set tubing was found open prior to use, and no luer lock was attached to the iv.The following information was provided by the initial reporter: "bottom of tubing is completely open, not leur lock to attach to a iv complaint noticed: prior to use".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD ALARIS¿ SECONDARY SET
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
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16080780
MDR Text Key308480323
Report Number9616066-2022-02097
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K790582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number11448964
Device Lot Number22089289
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-