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

Model Number 685M

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  malfunction  

Manufacturer Narrative

Initial 2 of 2.Common device name: tape and bandage, adhesive.Product code: kgx.(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 was torn/crushed".Photos depicting the reported complaint issue were provided by the complainant.The product was not used.

Manufacturer Narrative

The identified 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¿ is associated with golden investigation rci (b)(4).Photograph and samples have been received for this complaint, where is visible damage of primary pack on shorter side.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, ref: 685m and manufacturing lot #0k01975.The securement were produced, visually checked under subassembly lot 0k00861 produced in october 2020 and lot 0j01383 produced in september 2020 on manual operation station c080 and then packed into the peelpacks (pouch) under lot 0k01975 at 21st of october 2020 on center c2 on machine p013, with total lot amount (b)(4)pcs.Lot # 0k01975 was sterilized under certificate 2173-14752a 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 br41-013.No nonconformance has been registered during the manufacturing process of the affected lots and of the mention issue.No other complaint was registered on the lot 0k01975 and malfunction code.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¿.This complaint is within scope of investigation event tw#(b)(4)- 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 tw1454183 is in progress.Lot 0k01975 was manufactured before implementation of corrective actions.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

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: 12466594
• MDR Text Key: 272439082
• Report Number: 3005778470-2021-00376
• 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: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• 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: 685M
• Device Lot Number: 0K01975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1