MAUDE Adverse Event Report: UNOMEDICAL ZAVODSKAYA STREET 50 TBD; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number 26014182

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 1.Brand name: unovac low vacuum drainage.(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 "the low pressure redon does not hold a vacuum, it does not cause pressure" the drain was simply changed.¿ no harm reported.No photographs depicting the reported complaint issue were received from the complainant.Multiple attempts to collect additional information was conducted, but no response was received.

Manufacturer Narrative

Corrected outcome attributed to adverse event from required intervention to prevent permanent impairment /damage as this is not applicable to the reported event description and therefore, removed.Corrected investigation conclusions from manufacturing deficiency to conclusion yet available for correctness.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.

Event Description

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

Event Description

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

Manufacturer Narrative

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.Ncr 1404861 ¿unovac does not hold a vacuum¿ was initiated to investigate the issue.On the base of information received the investigation concludes that the true root cause for the issue ¿loss of vacuum in one unovac product (ref (b)(4)) of batch 332146 was identified by customer during use¿ cannot be identified.No additional actions are required at the moment.No additional investigation is needed.This issue will be monitored through the post market product monitoring review process 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.

• Brand Name: TBD
• 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: 10573436
• MDR Text Key: 208154459
• Report Number: 3007966929-2020-00035
• 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,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26014182
• Device Lot Number: 332146
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1