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

Model Number 40222182

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

Mdr 3007966929-2019-00056 / device 4 of 4.(b)(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 (ncr) related to complaint issue were initiated for the complaint order during production.A non-conformance ¿handyvac drain broken under surgery (detached short tube)¿ was previously initiated to investigate complaint issue.On a base of the available information the investigation reveals the likely cause for the issue as hard to clamp the deht tube with new clamp.The contributing cause for the issue is the tube with new deht material changes properties with time and connection between tube and the bushing connector weaken.As a result, user has to apply the force when working with handyvac product (clamp tube) while the connection between tube and the bushing connector weaken.So, tube is separated from the bushing connector when working with handyvac product, including when the patient is mobilized, or when the patient turns in bed.Pictures were received, defect is confirmed.Investigation performed via previous non-conformance for ¿handyvac drain broken under surgery (detached short tube)¿ is valid.No samples were received for complaint.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 "handyvacs wound draining used, all failed, became disattached at sealed join".Additional information was obtained on april 05, 2019 stating ¿as the device was double bagged and covered in blood, i was unable to determine exactly where the device had failed.I felt around the bag and think the seal between the bellows and the tubing near where the cable tie is used is where the fail occurred.I believe that the glued joint failed but, cannot confirm.I was unable to interview any staff that witnessed the event so am unsure if all four handivac¿s were used on one patient or if there were more patients.The nurse unit manager, directed her theatre receptionist to contact us and i was able to speak with an anesthetic nurse that did not witness the event but, was aware of it.There was no-one available to interview.The note on the unit available to me suggested that all units were used on one patient under the care of doctor.¿ photographs depicting the reported complaint issue was submitted by the complainant.Product was used on patient, 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: 8930291
• MDR Text Key: 183958856
• Report Number: 3007966929-2019-00056
• 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
• 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: 07/01/2023
• Device Model Number: 40222182
• Device Lot Number: 320573
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1