MAUDE Adverse Event Report: ARGON MEDICAL DEVICES DRAINAGE BAG CONNECTING TUBE MALE TWS

Catalog Number 404043015

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

The sample is indicated as unavailable for evaluation.Without the sample or any images to review, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be provided.

Event Description

When replacing the pyelostomy catheter, the tube that should have been spliced onto the catheter fell off.It was good that it fell off because with a smaller hole there had been a small leak, but an entrance for bacteria.

• Brand Name: DRAINAGE BAG CONNECTING TUBE MALE TWS
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• Manufacturer Contact: gina liu ; 1445 flat creek rd, athens, tx 75751
• MDR Report Key: 10855315
• MDR Text Key: 217984418
• Report Number: 1625425-2020-00712
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 404043015
• Device Lot Number: 11302751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other