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

Model Number 680M

Device Problem Unsealed Device Packaging (1444)

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

Event Type  malfunction  

Manufacturer Narrative

Initial 2 of 3.(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.(b)(4).

Event Description

It was reported by the product distributor that the "package is open".Not used on a patient, no harm reported.A photograph was received depicting the reported complaint issue.

Event Description

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

Manufacturer Narrative

Correction (g1): contact office address: (b)(6).Photograph has been received for this complaint, where is visible opened 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: (b)(4) and manufacturing lot # 0c02508.The securement were produced, visually checked under subassembly lots 0a06095 from (b)(6) 2020 till (b)(6) 2020 and 0b02763 from (b)(6) 2020 till (b)(6) 2020 on manual operation station c080 and then packed into the peelpacks (pouch) under lot 0c02508 from (b)(6) 2020 till (b)(6) 2020 on center c2 on machine p013, with total lot amount 71 400 pcs.Lot # 0c02508 was sterilized under certificate 2173-9965a 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.Machine logbook of machine p013 was checked, and some notices of machine repair related to claimed failure was found during production of lot 0c02508.Paper feed and cutting of peel-packs were set up.Issue with opened peel-pack is visible.Most probable reason of the failure is that operator or technician didn´t separate non-conform products.No nonconformance has been registered during the manufacturing process of the affected lot 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¿.One other complaint was registered on the same lot and malfunction code (tw 1439861 ¿ package broken), but issue is different and will be investigated within separated event tw1441684.This complaint is within scope of investigation event tw#1442722: package is open: securement (uno drain fix s 25/200 ster int).The most probable root cause resulted from the investigation ir21-006-mic (ver.1) were identified: rc1: incorrect position of pre-printing layout on the paper.Rc2: paper replacement procedure not followed.Rc3: inattention of the operators.Investigation report ir 21-006-mic (ver.1) /tw1442722 was approved at crb-c5/qa/wh-mic held on (b)(6) 2021 by meeting attendants.Capa will be open.Based on the investigation results the issue is considered to be isolated.The investigation associated with related event tw1441687 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: 11435076
• MDR Text Key: 244159373
• Report Number: 3005778470-2021-00110
• 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: 12/11/2020

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: 02/01/2023
• Device Model Number: 680M
• Device Lot Number: 0C02508
• 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