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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMALLBORE 6 INCH EXT VLV; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMALLBORE 6 INCH EXT VLV; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 20039E
Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  malfunction  
Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of tubing kinked could not be verified due to the product not being returned for failure investigation.A device history record review for model 20039e lot number 20125924 was performed.The search showed that a total of 24,003 units in 1 lot number was built on 10dec2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 20039e lot number 20125584 was performed.The search showed that a total of 24,003 units in 1 lot number was built on 04dec2020.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, an investigation could not be performed and a root cause could not be determined.".
 
Event Description
It was reported that a smallbore 6 inch ext vlv was clogged and had tubing kink during use.The following was reported by the initial reporter: "clinician opens the iv start kit.Then they open the bd iv extension set, tubing, 6".The tubing has a "crimp" and will clog or block the iv solution from going through the tubing set.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 6/7/2021.H.6.Investigation: one sample was received or quality investigation.The customer complaint of tubing kinked was not verified by inspection.Visual inspection of the tubing did not indicate any visual holes or damage to the extension set.The tubing of the extension set was then examined for any kinks or damage to the tubing cause by the clamp.Kinks can be cause by the clamp however, the kinks were easily massaged out and there was no leakage or occlusions caused by the kinking.A device history record review for model 20039e lot number 20125924 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 20039e lot number 20125584 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be determined because the reported failure could not be replicated.
 
Event Description
It was reported that a smallbore 6 inch ext vlv was clogged and had tubing kink during use.The following was reported by the initial reporter: "clinician opens the iv start kit.Then they open the bd iv extension set, tubing, 6".The tubing has a "crimp" and will clog or block the iv solution from going through the tubing set.".
 
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Brand Name
SMALLBORE 6 INCH EXT VLV
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 Key11925069
MDR Text Key263496759
Report Number9616066-2021-51236
Device Sequence Number1
Product Code FPA
UDI-Device Identifier27613203013820
UDI-Public27613203013820
Combination Product (y/n)N
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/10/2023
Device Model Number20039E
Device Catalogue Number20039E
Device Lot Number20125924
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2021
Date Manufacturer Received06/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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