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

Model Number 680M

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

Patient Problem No Patient Involvement (2645)

Event Type  Injury  

Manufacturer Narrative

Mdr 3005778470-2020-00218 / device 1 of 1 (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.Fda registration number reporting site: 1049092 manufacturing site: 3005778470.

Event Description

It was reported "there was foreign body found on the device".The product was not used, no harm reported.A photograph depicting the reported complaint issue was submitted by the complainant.

Manufacturer Narrative

A batch record review indicates no discrepancies.Photo has been received for this complaint.Uno drain fix s (25/200)ster int in question was manufactured under sap material id: (b)(4), ref: 680m and manufacturing lot # 0c02508.The securement were produced, visually checked under subassembly lots 0a06095 from 07th of february 2020 till 22nd of february 2020 and 0b02763 from 21st of february 2020 till 05th of march 2020 on manual operation station c080 and then packed into the peelpacks (pouch) under lot 0c02508 from 24th of march 2020 till 26th of march 2020 on center c2 on machine p013, with total lot amount (b)(4).Lot # 0c02508 was sterilized under certificate (b)(4) 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 (b)(4) for packing of sterile securements products and recorded in (b)(4).Visual inspection of securement products acc.To (b)(4) was performed by quality assistant on beginning of order, on beginning of every shift and after every hour.Packaging was done on p013 according to the process instruction (b)(4) for packing of sterile securements products.Review of the dhr showed that all relevant tests required during the manufacturing process, packaging process and final product release has been fulfilled and met the requirements.No nonconformity has been registered during the manufacturing process of the mentioned lot.No nonconformity has been registered for used raw materials.No other similar complaint was received on the product and malfunction code since 2017.During production of lot 0c02508 were used packing raw materials: packing foil sap code (b)(4) with batch numbers 0001472525, 0001472528, 0001439528 and packing paper sap code (b)(4) with batch numbers 0001316291 and 0001442544.Incoming inspection for material (b)(4) with batch numbers 0001472525, 0001472528, 0001439528 were in accordance with material specification mt58-005 v.4.0.Materials were released based on control of certificates.Certificates were reviewed and they were in accordance with (b)(4) incoming inspection for material (b)(4) with batch numbers 0001316291 and 0001442544 were in accordance with material specification (b)(4).Materials were released based on control of certificates.Certificates were reviewed and they were in accordance with (b)(4) issue was discussed on (b)(4) on 27th of january 2021.It was decided, that is not necessary to open nonconformity and complaint investigation can be closed, because it is not possible to determine the origin of the foreign body from the available picture.It is also difficult to determine the location of the impurity from the picture, whether is placed on packing foil, on packing paper or inside of peel pack as separate body.Technicians and operators did not observe this issue during production and packaging process.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.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
• MDR Report Key: 11021722
• MDR Text Key: 222322576
• Report Number: 3005778470-2020-00218
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/01/2023
• Device Model Number: 680M
• Device Lot Number: 0C02508
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1