MAUDE Adverse Event Report: COLOPLAST A/S UNKNOWN; FLUSH URETERIC CATHETER

Model Number ACP2051002

Device Problem Device Markings/Labelling Problem (2911)

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 not able to be used due to wrong product.The product inside the packaging did not match the labeling.No other adverse patient effects were reported.

Manufacturer Narrative

We have been informed about a defect product, on a ureteric catheter.According to the complaint description lot number and sample are available.The quality databases reveal other complaints for the lot number 8742583 and a corrective and preventive action is ongoing capa-000054 "wrong product in packaging ac5405 instead of acp205" opened on april 2023.Documentary and traceability investigation showed a labelling issue into intermediate product at the production and logistics level, ac540580 was labeled as acp20580 and conduct to this packaging error.A risk evaluation was conducted through capa to analyze the situation and showed that risks are adequately controlled and reduced as far as possible in the state of art.Based on this, the residual risks are adequately controlled and reduced as far as possible, and the residual risk associated with the use of the product are acceptable when weighed against the benefits to the patient/user.It is concluded that the risks identified are still acceptable and considered as safe.

• Brand Name: UNKNOWN
• Type of Device: FLUSH URETERIC CATHETER
• 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: 16782391
• MDR Text Key: 313706659
• Report Number: 9610711-2023-00062
• Device Sequence Number: 1
• Product Code: EYB
• Combination Product (y/n): N
• PMA/PMN Number: K171043
• 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: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACP2051002
• Device Catalogue Number: ACP205
• Device Lot Number: 8742583
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2022
• 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