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

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.

• 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 Key: 11920637
• MDR Text Key: 257198084
• Report Number: 3007966929-2021-00308
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 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 Date: 05/01/2023
• Device Model Number: 40227182
• Device Lot Number: 335947
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1