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

Model Number 40222182

Device Problems Suction Problem (2170); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 1.(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 physician was trialing the handyvac wound drainage system on a double mastectomy patient would not maintain negative pressure.It was reported that the product was used for three (3) hours.It was further reported that when the scrub nurse prepares the drain (compresses bellows as per instructions, close both clamps, attach drainage bag, the bellows are compressed as expected.We then open bottom clamp while it sits on the scrub nurse tray in theatre.Twenty (20) minutes later when they are ready to insert the drain, we see the handyvac system on the trolley with the bellows fully expanded." there was no harm reported to the patient.A photograph depicting the reported complaint issue were submitted by the complainant.It was noted on the photograph received ¿i concertina-d the bellows six (6) times and it¿s still expanding.I¿m sorry i have to give up on these.¿.

Manufacturer Narrative

A batch record review was performed.No ncr related to complaint issue were initiated for complaint order during production.No samples were received.Picture was received, but it does not demonstrate any defect.Product was produced in (b)(6) 2016.We have performed the investigation via ncr 1382290 for ¿handyvac cannot hold the vacuum¿.Based on the available information the investigation revealed the likely causes for the issue is 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 begins 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.This is 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.This lot was manufactured in 2016.Changes to address this issue have been implemented or are in process.No additional investigation is needed at the current moment.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.

Event Description

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

• 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: 10388527
• MDR Text Key: 202596647
• Report Number: 3007966929-2020-00030
• 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
• Report Date: 07/29/2020

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: 10/01/2021
• Device Model Number: 40222182
• Device Lot Number: 304732
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1