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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL ZAVODSKAYA STREET 50 L3C2250 - UNO OR/WOUND DRAINAGE; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

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UNOMEDICAL ZAVODSKAYA STREET 50 L3C2250 - UNO OR/WOUND DRAINAGE; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED Back to Search Results
Model Number 40227182
Device Problem Suction Problem (2170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Device 1 of 1.(b)(4).Correction: used previous model number, instead of new assigned part number.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
 
Event Description
It was reported that the "vacuum part does not hold the vacuum as it is supposed to".According to the complainant "all connections were secure and the product created vacuum, but lost it slowly".No photograph depicting the reported complaint issue.No harm reported.
 
Manufacturer Narrative
Correction (g1) - contact office address: (b)(6).A batch record review was performed.No ncr related to complaint issue were initiated for complaint order during production.No samples and pictures were received.Root cause investigation was performed via event tw #(b)(4) ¿handyvac cannot hold the vacuum¿.On the base of the available information the investigation reveals the likely causes for the issue the new deht tube material changes properties with time and the connection between the tube and male, female connectors weaken.As a result, the connector in the tube began to turn.After shifting the connector, a small ¿channel¿ is formed in the tube through which air can enter."channel" is an imprint of the line of contact between two parts of the connector during molding.It happened because the tube is too rigid and has lost elasticity.And handyvac can't work correctly.Capa tw #(b)(4) was opened to implement new deht material for handyvac tubes.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 3007966929.
 
Event Description
To date no additional patient or event details have been received.
 
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Brand Name
L3C2250 - UNO OR/WOUND DRAINAGE
Type of Device
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
Manufacturer (Section D)
UNOMEDICAL ZAVODSKAYA STREET 50
fe unomedical ltd
minsk region
minskaya voblasts
BO 
MDR Report Key11920637
MDR Text Key257198084
Report Number3007966929-2021-00308
Device Sequence Number1
Product Code GCY
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 05/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/01/2023
Device Model Number40227182
Device Lot Number335947
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 05/17/2021
Initial Date FDA Received06/02/2021
Supplement Dates Manufacturer Received06/03/2021
Supplement Dates FDA Received06/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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