MAUDE Adverse Event Report: UNOMEDICAL ZAVODSKAYA STREET 50 UNOMEDICAL OP-FLEX POOLE SUCTION SET; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE. NONPOWERED

Model Number 34071181

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

Mdr 3007966929-2020-00018 / device 1 of 1.(b)(6).Device date of manufacture: oct 2019.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 operation was about to begin, and the upper part of the suction had been removed.At this point a fly came out of the suction.Luckily, the suction had not yet been used." additional information was requested and received informing ¿we are unwrap the component prior to packing in to the ppack.The product was discarded.Yes, it was found after taking off the op-flex, so yes it was inside the device.¿ a photograph depicting the reported complaint issue was provided by the complainant.The product was not used on the patient, no harm reported.

Manufacturer Narrative

A batch record review was performed.No non -conformance report (ncr) related to complaint issue were initiated for complaint order during production.No samples were received.Picture was received and evaluated.Defect is confirmed on the base of picture.An ncr was initiated to investigate the issue.The intention of this investigation was to describe and identify the root causes for issue ¿foreign matter in the op-flex poole set/x-ray¿.On a base of the available information the investigation reveals: the root cause for the issue is not fully effective pest control at the factory.This is an isolated case.The following actions are planned to be implemented: add electronic fly killers in unprotected areas; control of maintenance electronic fly killer; additional protection during the movement of components along the conveyor.Retraining of service company on c705003 must be performed.A corrective/preventative action (capa) has been initiated.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: UNOMEDICAL OP-FLEX POOLE SUCTION SET
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE. NONPOWERED
• Manufacturer (Section D): UNOMEDICAL ZAVODSKAYA STREET 50; fe unomedical ltd; minsk region; minskaya voblasts
• MDR Report Key: 10098319
• MDR Text Key: 194390999
• Report Number: 3007966929-2020-00018
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 34071181
• Device Lot Number: 330291
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1