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

Model Number 40125182

Device Problems Suction Problem (2170); Detachment of Device or Device Component (2907); Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Mdr 3007966929-2019-00061 / device 4 of 6.Based on the available information, this event is deemed to be a reportable malfunction.A batch record review was performed.No non-conformance report related to complaint issue were initiated for complaint order during production.Manufacturing data for the affected handyvac products were reviewed for the period from may 01, 2016 to may 01, 2019.The complaints were reviewed for the period from (b)(6) 2016 to (b)(6) 2019, on the presence of the similar issue ¿drain will not keep vacuum¿.A total of two (2) complaints on seven defective items were received.Based on the medical review of the complaint, the product malfunction code was identified as disconnection of the drain from the drainage collection device; or connection is loose, leakage may occur.No harm was reported with the complaints.The calculated probability of the failure occurrence for 2016-2018 was performed, the risk has been evaluated as ¿low¿.No samples were received.Pictures were received.Pictures did not lead to any conclusions.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.(b)(4).

Event Description

It was reported that "the drain will not keep the vacuum.The problem could be, that the drain doesn´t fit well on the connector." photographs depicting the reported complaint issue were submitted by the complainant.No harm reported.

• 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
• Manufacturer (Section G): UNOMEDICAL ZAVODSKAYA STREET 50; fe unomedical ltd; minsk region; minskaya voblasts
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 8930931
• MDR Text Key: 166955996
• Report Number: 3007966929-2019-00061
• 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: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: 40125182
• Device Lot Number: 319821
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1