MAUDE Adverse Event Report: UNOMEDICAL ZAVODSKAYA STREET 50 L3C2250 - UNO OR/WOUND DRAINAGE

Model Number 40107181

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device 2 of 2.Procode: uno handyvac ch18 bag sw/tap (1/20) int.(b)(4).Affiliation: (b)(6) hospital.Based on the available information, this event is deemed to be a reportable malfunction.Should additional information become available, a follow up report will be submitted.(b)(4).

Event Description

It was reported "bellows does not hold vacuum.User need to activate the bellows repeatedly.Two of twenty product has this issue.Risk that the exudate will not leave the wound." no harm was reported.No photos provided.

Event Description

To date no additional patient or event details have been received.

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.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 3007966929.

• Brand Name: L3C2250 - UNO OR/WOUND DRAINAGE
• Manufacturer (Section D): UNOMEDICAL ZAVODSKAYA STREET 50; fe unomedical ltd; minsk region; minskaya voblasts ; BO
• MDR Report Key: 11699905
• MDR Text Key: 249495961
• Report Number: 3007966929-2021-00069
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40107181
• Device Lot Number: 330085
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1