MAUDE Adverse Event Report: COLOPLAST A/S VORTEK J CATHETER WITH STYLET; CATHETER, NEPHROSTOMY

Model Number RCJ1101002

Device Problem Break (1069)

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 had a break.The connector came off from the tube.No other adverse patient effects were reported.

Manufacturer Narrative

We have been informed about a defect product " connector came off" on a urine bag adapter.According to the complaint description sample is available but not the lot number.After receiving this complaint, we were unable to investigate further complaints and conduct documentary investigations to look for any anomaly recorded during production as the lot number is not available.Checking the quality databases did not reveal any anomaly in relation with the described defect.On 13th march, we received one used sample.We observed that it's the luer gluing on the pvc tubing was disconnected.We make an awareness of the operators regarding this defect product.

• Brand Name: VORTEK J CATHETER WITH STYLET
• Type of Device: CATHETER, NEPHROSTOMY
• 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: 16513465
• MDR Text Key: 311247243
• Report Number: 9610711-2023-00032
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• PMA/PMN Number: K211911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RCJ1101002
• Device Catalogue Number: RCJ110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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