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

Model Number 40105181

Device Problems Product Quality Problem (1506); Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a serious injury and 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

The nurse reported that during surgery, a piece of plastic came off the drain and went into the wound on the back of the patient.It was reported that a microscope was used during surgery, and the plastic piece was noticed when wound was ¿rinsed¿ and inspected under the microscope.The drain was removed from the patient and the surgeon was able to remove the plastic piece from the wound while using the microscope.The nurse reported that there was no harm to the patient, but operation lasted for a longer time due to this issue.No further patient or event details were provided.A photograph depicting the reported issue was provided.

Manufacturer Narrative

A batch record review was performed.No samples were received.No non ¿ conformance report (ncr) related to complaint issue were initiated for complaint order during production.A ncr for ¿flakes of drain transfers to tissue during use¿ was initiated to investigate the issue.A picture was received and evaluated.Based on the available information the investigation concludes that the true root cause for the issue is absence of maintenance procedure for tools used on the machinery.The contributing cause is quality control within the existing manufacturing flow.Following actions are planned to be implemented: to develop the maintenance procedure for tools used on machinery.To establish the preventative maintenance schedule based on the tool¿s frequency of use; to specify the requirements to quality control of punched drainage 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.(b)(4).

Event Description

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

• 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
• MDR Report Key: 7861739
• MDR Text Key: 119788675
• Report Number: 3007966929-2018-00014
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: 40105181
• Device Lot Number: 316306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1