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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7 IN KINK REST EXTENSION SET W/MAXPLUS; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7 IN KINK REST EXTENSION SET W/MAXPLUS; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MP9002-C
Device Problems Difficult to Remove (1528); Difficult or Delayed Separation (4044)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/13/2021
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.
 
Event Description
It was reported that a 7 in kink rest extension set w/maxplus was difficult to disconnect during use.The following was reported by the initial reporter: "needless connector will not disconnect from the extension set.Unable to do procedure if it is not removed.Connector was checked before being used on a patient, so there was no impact on patient care.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-06-21.H6: investigation summary: the customer reported the needleless connector will not disconnect from the extension set, and returned one used sample.The sample was unable to be disconnected, and the complaint is verified.The sample would not come apart even under wrench pressure.This is a known issue, and we do not recommend antiseptic device swabs that contain (chlorhexidine gluconate (3.15%) and isopropyl alcohol (70%), which testing in ambient lab conditions has shown requires a dry time of approximately two and a half minutes to completely dry.It was also observed that a slightly sticky residue is left behind after drying is complete.The combination of the two component surfaces still being wet when connected (customer is using a 10 second dry time per previous investigations), and the chlorhexidine gluconate residue, was observed to bond the two surfaces together during functional testing.Please allow some dry time after swabbing the maxzero and maxplus components with alcohol.A device history record review for model mp9002-c lot number 20075198 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 04jul2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
 
Event Description
It was reported that a 7 in kink rest extension set w/maxplus was difficult to disconnect during use.The following was reported by the initial reporter: "needless connector will not disconnect from the extension set.Unable to do procedure if it is not removed.Connector was checked before being used on a patient, so there was no impact on patient care.".
 
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Brand Name
7 IN KINK REST EXTENSION SET W/MAXPLUS
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
MDR Report Key11980358
MDR Text Key256204654
Report Number9616066-2021-51308
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50885403236769
UDI-Public50885403236769
Combination Product (y/n)N
PMA/PMN Number
K051499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMP9002-C
Device Catalogue NumberMP9002-C
Device Lot Number20075198
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2021
Date Manufacturer Received06/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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