MAUDE Adverse Event Report: UNOMEDICAL S.R.O. L3C1950 - UNO OR/SECUREMENT

Model Number 685M

Device Problems Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

Mdr 3005778470-2021-00501 / device 1 of 1.Common device name: tape and bandage, adhesive.Product code: kgx.(b)(4).(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 by the product distributor that the "product was sealed together with outside the plastic bag".Photographs received depicting reported complaint issue.Product was not used, no harm reported.

Manufacturer Narrative

The product was manufactured under product specification pr60-136 ver 6.0.A batch record review was conducted resulting in the following: urinary catheter in question was manufactured under sap material id 1266041, uno female str ch14/18cm (100/1000) int and manufacturing lot # 0l03005 in c2 in amount (b)(4) pcs at machine p010 in november 2020.The product was packed according to the instruction for packing g905703 v.65 packaging products on packaging machines.The catheters were produced under subassembly lot 0l02956 at machine a098 on november 24-25 th 2020 in accordance to g905500 ver 41 section 5.11.Subsection 4 operators have to visually inspected each catheter.No foreign bodies including oil stains are allowed.Review of the dhr 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 lot.The picture related to the complaint was received and inspected.The black marks on catheters were observed.The issue was confirmed.Tw #(b)(4) was open to solve the issue on machine a098 in february 2021.As the cause of the issue was determined following: the pin in the holder came loose over time and rubbed against the guide rails.Fine particles of iron and plastic were released from the fixing holder.Monthly maintenance was performed on the machine and all tools were cleaned.As a corrective action the guide rail was replased with new one.The retraining of the relevant operators was carried out.A query was run against all urinary catheters and malfunction codes uca-pmc09.02 foreign matter within product & uca-pmc9.02 foreign matter within product on november 15th 2021 which yielded two occurrences - tw#(b)(4) and (b)(4) past 12 months.Both complaints were received from the same complainant.This issue will be monitored through the post market product monitoring review process 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.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
• 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: 12863230
• MDR Text Key: 282337301
• Report Number: 3005778470-2021-00501
• 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: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/01/2024
• Device Model Number: 685M
• Device Lot Number: 1B04105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1