MAUDE Adverse Event Report: UNOMEDICAL S.R.O. L3C1950 - UNO OR/SECUREMENT; TAPE AND BANDAGE, ADHESIVE

Model Number 680M

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device 3 of 3.(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 thee was "oil ink on the package".This emdr is to capture the unknown quantity affected.

Manufacturer Narrative

A batch record review indicates no discrepancies.One photo has been received for this complaint, which was evaluated in accordance with wi-0359.On photo is visible grease-like substance on paper backing.Batch record review was conducted resulting in following: uno drain fix s (25/200)ster int in question was manufactured under sap material id: (b)(4) , ref: 680m and manufacturing lot # 1l00871.The securements were produced, visually checked under subassembly lots 1j03709 produced in september/october 2021, 1k01758 produced in october/november 2021 and lot 1k04595 produced in november 2021 on manual operation station c080 and then packed into the peelpacks (pouch) under lot 1l00871 from 08th ¿ 11th of november 2021 on center c2 on machine p013, with total lot amount 71 (b)(4) pcs.Lot # 1l00871 was sterilized under certificate 2173-24288a and released based on the review of results of sterilization provided by sterilization company steris.All the results were within specification and products were released in compliance with (b)(4).The production process, in-process control, testing result, packaging of products run according to the process instruction pi41-017 for subassembly process drainfix.Visual inspection of securement products acc.To tm-296sk was performed by quality assistant on beginning of order, on beginning of every shift and after every hour.Packaging was done on machine p013 according to the process instruction pi41-013 for packing of sterile securements products.During packing process following tests are performed: burst test to evaluate strength of the weld, water leakage test for detection of holes in primary pack, peel test to check correct opening of the seal and 100% visual inspection for detection of any defects on packing.Based on the available record, all tests were performed, and all results were within specification.Review of the dhr showed that all relevant tests required during the manufacturing process, packaging process and final product release had been fulfilled and met the requirements.No nonconformity has been registered during the manufacturing process of the mentioned lots.No another complaint was received for affected lot 1l00871 and mentioned issue.This complaint is associated with related event (b)(4) opened on 27th of september 2019.Within the investigation was confirmed that the contamination has surfaced through the paper structure, but the fibers can be seen intact without degradation or dissolvement from the contaminant.Spectral analysis confirms that the source of the contamination is located inside the sterile barrier and that the contamination occurred from inside, specifically from the devices hydrocolloid material.Hydrocolloid material is a part of the drain-fix device.The investigation carried out by ccc r&d slovakia confirmed that the peel paper of drain-fix securement device was not affected by the contaminant and thus should have kept its sterile barrier.Based on above was determined that the issue is related to the hydrocolloid material behavior and the sterile barrier of device is not affected.It is a cosmetic issue only.During investigation ir-19-025-mic (version 1.0) were identified three root causes: rc1 - there is no barrier between paper and product.Rc2 - paper is not designed to be durable against pollution/contamination from the product.Rc3 - products are placed in not suitable way into peel packs.Investigation was reviewed and approved on crb c5/qa - mic held on 30/oct/2019.Corrective and preventive actions were covered within capa (b)(4) paper packaging soiled opened on 13/nov/2019.The actions included in the capa plan could be closed as it was confirmed and documented in the investigation report ir_19-025-mic/(b)(4) v.1.0 that the defect is cosmetic only and a functionality of products is not impacted.Overall risk associated with reported issue is low.It was also proved that sterile barrier is not breached and sterility of product is not impacted.Stains visible on primary packaging come from product itself specifically from hydrocolloid material what was confirmed by ir spectrometry.All tested samples with soaked areas on packaging paper passed burst test tm-409 and leak test tm-515.Considering information above it was agreed by crb to close/cancel capa event.Opportunity for improvement was opened under (b)(4) to evaluate additional options for eliminating of stains on primary packaging.(b)(4) is now in close-done state.The investigation event (b)(4) has been approved and is complete.No additional action is required, and this complaint will be closed.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:3005778470.

Event Description

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

• Brand Name: L3C1950 - UNO OR/SECUREMENT
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer (Section G): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14024960
• MDR Text Key: 288702697
• Report Number: 3005778470-2022-00023
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

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?: Yes
• Device Operator: Other
• Device Model Number: 680M
• Device Lot Number: 1L00871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1