MAUDE Adverse Event Report: COLOPLAST A/S VORTEK SINGLE LOOP URETERAL STENT

Model Number ACA1071002

Device Problem Delivered as Unsterile Product (1421)

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

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, this device was reported to have the sterile inner packaging not sealed.No other adverse patient effects were reported.

Manufacturer Narrative

According to the complaint description lot number is available but no sample.The review of the complaint history database, revealed no trends for the lot number 8899289.The product reference aca1071002 lot number 8899289 has been manufactured for (b)(4) pieces in november 2022.The expiry date is november 2027.This product is a set packaged at out hungary site.On 13th january hungary site was informed about this issue.Checking the quality database showed no anomaly in relation with the described defect.Hungary's investigation: we package this item on the 1ss2 manual cell.Here we receive bags which we place the items in.During our process we only weld one side of the package.Without sample or photo it is hard to determine who made the mistake.Could have been that the supplier gave us packages without welding or we didnt weld the one side during packaging.Visual inspection is 100% during packaging on this cell.In both case the operator should have noticed the missing welding.I trained the operators about this kind of failure and the critical processes in production in may, 2023.New training is not needed.

• Brand Name: VORTEK SINGLE LOOP URETERAL STENT
• Type of Device: URETERAL STENT
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16178852
• MDR Text Key: 307806446
• Report Number: 9610711-2022-00112
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K201436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2018
• Device Model Number: ACA1071002
• Device Catalogue Number: ACA107
• Device Lot Number: 3659028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/16/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 04/25/2023
• Date Device Manufactured: 06/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1