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

Model Number 40105181

Device Problem Suction Problem (2170)

Patient Problem Hematoma (1884)

Event Date 06/14/2020

Event Type  Injury  

Manufacturer Narrative

Device 1 of 1 (b)(6).Based on the available information, this event is deemed to be a serious injury.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 product cannot keep the vacuum, even though the harmonica is pressed together and the two clamps open.There is reported a hematoma and a re-operation.But it is uncertain if the malfunction of the handyvac is the course of this ".The end user did not note any issue with the product before use but, ¿during use the vacuum is fading and end up with no vacuum.This despite the product is used correctly.Everything looks right and normal before use".No photographs depicting the reported complaint issue was submitted with the complaint.

Manufacturer Narrative

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

It was further reported that it is uncertain if the malfunction of the hadyvac is the course of the hematoma and re-operation.The reporter states this issue is too often discovered on handyvac and the nurses are frustrated.This issue is found on approx.50% of this lot.The reference number could not be obtained by the customer, but the lot number was confirmed.Additional follow up information confirmed, the device was used on "not 20 different patients, but several different.The number is uncertain." every product was examined after use for blocked tubes or other obvious reasons for the malfunction lack of vacuum.The complainant has used handyvac for several years and knows the product well.The reporter states the product stays compressed for some hours, after connecting to drain and opening of clamps but it differs from product to product.The reporter confirmed the bellows were not squeezed while losing vacuum.The reporter confirmed the tubes were not deformed after the clamp was released.The reporter states "it does not work when vacuum is gone and it differs from product to product when the vacuum took off, sometimes already at operating room (or) and others when patient had went to the ward.".

Event Description

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

Manufacturer Narrative

A batch record review was performed.No non-conformance record (ncr) related to complaint issue were initiated for complaint order during production.No samples and pictures were received.Ncr ¿handyvac cannot hold the vacuum¿ was initiated to investigate the issue.On a 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.A corrective/ preventative action (capa) was opened for implement new deht material for handyvac tubes.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: HANDYVAC
• 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: 10236253
• MDR Text Key: 198536889
• Report Number: 3007966929-2020-00022
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 40105181
• Device Lot Number: 330084
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1