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

Model Number 680M

Device Problems Unsealed Device Packaging (1444); Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 3.Complainant street address: (b)(6).Distributor: (b)(4).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 (b)(4).

Event Description

It was reported by the product distributor that there was a "foreign body found on the device", however photos received show the product had a ripped package.The product was not use, no harm reported.A photograph depicting ripped packaging was received by the complainant.

Event Description

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

Manufacturer Narrative

Correction (g1) - contact office address: (b)(6).Photograph and samples have been received for this complaint, where is visible damage of primary pack.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 29th 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 (b)(4).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.Review of the dhr showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.The process parameters were adjusted within the validated window.The packaging of products was run according to the process instruction pi41-013 for packing of sterile securements products and recorded in (b)(4).No nonconformance has been registered during the manufacturing process of the affected lots and of the mention 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 (e.G.Water marks, stains), or securement or loose material is trapped in packaging¿.No similar complaint was registered on the lot 0c02508 and mentioned malfunction code.Incoming material used during production of lot 0k01974 was checked.It was used packing paper ppr gas uno drn-fix 415mm ¿ sap code 1256437g3, lots 0001608419 and 0001557577.Incoming inspection for material 1256437g3 with batch numbers 0001608419 and 0001557577 were in accordance with material specification mt50-017.Materials were released based on control of certificates.Certificates were reviewed and they were in accordance with mt50-017.This complaint is within scope of investigation event tw#1442721 - package broken securement (uno drain fix s 25/200 ster int).The most probable root cause resulted from the investigation ir21-005-mic (ver.1) were identified: rc1: neglect of the operator, rc2: control of cutting knives is not included in process instruction, rc3: pre-printed printing on paper floats to the sides of the paper, rc4: inattention of the operators, investigation report ir 21-005-mic (ver.1) / (b)(4) was approved at crb-c5/qa/wh-mic held on 26-apr-2021 by meeting attendants.Based on the investigation results the issue is considered to be isolated.Capa will be open.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.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.

• 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: 11435136
• MDR Text Key: 243527317
• Report Number: 3005778470-2021-00107
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 05/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1