MAUDE Adverse Event Report: UNOMEDICAL ZAVODSKAYA STREET 50; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number 115.06.058

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Unomedical y-suction catheter.Expiration date: 03/2023.(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 foreign substance was observed in the packaging of the suction catheter.Photos depicting the reported complaint issue were provided by the complainant.

Event Description

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

Manufacturer Narrative

No physical sample has been received.A photograph has been received for this complaint, which was evaluated in accordance with work instructions.The sample on the photograph did not meet requirements standard operating procedure general quality requirements point a12 no foreign matter in peelpack.A batch record review was conducted resulting in the following: urinary catheter in question were manufactured under material identification number 1300225 and manufacturing lot # 8d00574 in amount 9000pcs.The catheters were assembled under subassembly lots 8c05079 and 8a06150 on machine a036 in january and april 2018, then packed in peelpacks (pouch) under lot 8d00574 on 7- 8 of april 2018 on packaging machine p013.The production process run according to the process instructions.A visual inspection of catheters according to testing methods is a part of in process inspection.Then the product was packed according to the instruction for packing , lot # 8d00574 was sterilized under lots 25a180410 and 26a180424.Review of the device history records showed that all relevant tests required during the manufacturing and packaging process and final product release had been fulfilled and met the requirements.No nonconformity had been registered during the production process of the mentioned lots.The evaluation of the provided sample on the photo resulted in a discrepancy.Based on received photo the issue is related to burn mark in film.A non-conformance was opened but, it now closed.During the lot production 80-micron packaging film was used that was replaced by mlp 120 micron packaging film in (b)(6) 2018 within ccr-01184 for product 1300225.80-micron packaging film is no longer used.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.

• Type of Device: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): UNOMEDICAL ZAVODSKAYA STREET 50; fe unomedical ltd; minsk region; minskaya voblasts
• MDR Report Key: 8272176
• MDR Text Key: 134065053
• Report Number: 3007966929-2019-00002
• Device Sequence Number: 1
• Product Code: BSY
• 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: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 115.06.058
• Device Lot Number: 8D00574
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1