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

Model Number 685M

Device Problem Delivered as Unsterile Product (1421)

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

Event Type  malfunction  

Event Description

It was reported by the product distributor that the "packages didn't seal very well".Photos provided showing product is caught in the packaging weld.The products were not used, therefore, no harm reported.

Manufacturer Narrative

Device 1 of 1.Common device name: tape and bandage, adhesive.Product code: kgx.Complainant street address: (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).

Manufacturer Narrative

Additional information was received 5/5/2022 that indicated two devices were affected versus one initially reported.Emdr (b)(4) has been created to address the second device.Batch record review was conducted resulting in following: uno drain fix 685 m (20/160)ster int in question was manufactured under sap material id 1301278 and manufacturing lot # 1c03887.The securement was produced, visually checked under subassembly lots 1c02360 and 1a02912 on machine c080 and then packed in peelpacks (pouch) under lot 1c03887 on april 2021 on center c2 on machine p013, with total lot amount (b)(4).Lot #1c03887 was sterilized under lot 2173-18676a 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 sop-000801.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 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 other complaint was registered on the lot and malfunction code¿ sec-pmc07.06 primary pack (sterile products) has incomplete or open seal / weld, or is torn, ripped or contains holes or exhibits external contamination¿¿.Issue is related to capa tw1322007 - drainfix packaging issue.It was determining capa action: 1.Update pi41-013 for correct inserting the products to the cavities - packaging work instruction.Capa is in close-done state.Product with lot 1c03887 was manufactured after implementation of capa tw1322007.Most probable reason of the failure is that operator didn´t separate non-conform products.No more defective products were found, so we consider this issue as isolated mistake.We will monitor if there is rising trend of complaints related to the issue in question.All available relevant operator will be re-trained on pi41-013.No containment action is needed, because all information about use of sterile product is shown on each peelpack and also in insert for use.The ifu says ¿do not use if the package is damage¿.Also dhf 1073 says, that intended user is healthcare professionals.So, the risk of using of products with damaged peelpack is minimal as only the healthcare professional can apply the product.From 31st of may is established increased control of products during packing process.Extra operator has been added to carry out visual inspection.No products sealed into the peelpack has been found yet.We register 2 complaints on the issue product sealed into the peelpack, where products were manufactured after implementation of capa tw1322007.Both lots were manufactured before implementation of increased control with one operator extra.During packing process of first complaint was present also new operator.The investigation associated with related event (b)(4) has been approved and is complete.No additional action is required and this complaint will be closed.This issue will be monitored through the post market product monitoring review process, sop-000741.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 by the product distributor that the "packages didn't seal very well".Photos provided showing product is caught in the packaging weld.The products were not used, therefore, no harm reported.Additional information was received (b)(6) 2022 that two pieces were affected.

• 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: 13395441
• MDR Text Key: 286926602
• Report Number: 3005778470-2022-00002
• 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: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/01/2024
• Device Model Number: 685M
• Device Lot Number: 1C03887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1