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

Initial reporter complainant city: (b)(6).Affiliation: (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 "the packaging is leaking and is no longer sterile." no photo was provided.The product was not used.

Manufacturer Narrative

This emdr follow-up 2 is for corrected investigation as stated below: batch record review was conducted resulting in following: uno drain fix s (25/200)ster int in question was manufactured under sap material id: 1301277, ref: 680m and manufacturing lot # 0k01974.The securement were produced, visually checked under subassembly lots 0j00258 from 17th of september 2020 till 29nd of september 2020 and 0j04006 from 29st of september 2020 till 16th of october 2020 on manual operation station c080 and then packed into the peelpacks (pouch) under lot 0k01974 from 19th of october 2020 till 21st of october 2020 on center c2 on machine p013, with total lot amount 67 200 pcs.Lot # 0k01974 was sterilized under certificate 2173 ¿ 14751a 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 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.One another similar complaint was received for affected lot and malfunction code, but issue was different: tw1439885 - package broken.This complaint is associated with related event tw #1283671 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 are covered within capa tw1301702 paper packaging soiled opened on 13/nov/2019.Capa is in progress and they were determined capa actions: to implemented changed assembly process of drain fix small and large, new tool for assembly to be created, drawings of drain fix small and drain fix large to be updated, training of relevant operators on new versions of pi and drawings.Final version of capa plan (ver-1.0) was reviewed on ad hoc crb-c5/qa-mic meeting held on 15/nov/2019 and approved by meeting attendants.The investigation event tw #1283671 has been approved and is complete.No additional action is required, and this complaint will be closed.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: (b)(4), manufacturing site: (b)(4).

Event Description

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

Manufacturer Narrative

Batch record review was conducted resulting in following: uno drain fix s (25/200) ster int in question was manufactured under sap material id 1301277 and manufacturing lot # 0h01076.The securements product sap number 1258406 were produced, visually checked under subassembly lots 0f00336, 0g01324 on machine c080 and then packed in peelpacks (pouch) under lot 0h01076 in august 2020.Product manufactured on center c2 on machine p013, with total lot amount (b)(4) pcs.Lot #0h01076 was sterilized under lot 2173-13185a 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 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.One another similar complaint was received for affected lot and malfunction code.This complaint is associated with related event tw #(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 are covered within capa tw1301702 paper packaging soiled opened on 13/nov/2019.Capa is in progress and they were determined capa actions: - to implemented changed assembly process of drain fix small and large.- new tool for assembly to be created.- drawings of drain fix small and drain fix large to be updated.- training of relevant operators on new versions of pi and drawings.Final version of capa plan (ver-1.0) was reviewed on ad hoc crb-c5/qa-mic meeting held on 15/nov/2019 and approved by meeting attendants.The investigation event tw #(b)(4) has been approved and is complete.No additional action is required, and this complaint will be closed.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: 12631857
• MDR Text Key: 276394092
• Report Number: 3005778470-2021-00485
• 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,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: 680M
• Device Lot Number: 0K01974
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1