MAUDE Adverse Event Report: COOK INCORPORATED COOK; CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY

Model Number G07774

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 05/03/2022

Event Type  malfunction  

Event Description

Two cook 18fr multipurpose drains had the locking string fail.We only stock two of this size in the department, so we had to use a smaller drain.May effect outputs of abscess.

• Brand Name: COOK
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 14631011
• MDR Text Key: 293563540
• Report Number: 14631011
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/05/2022

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 Model Number: G07774
• Device Catalogue Number: ULT18.0-38-25-P-6S-LMCL
• Device Lot Number: 14454436 AND 14284482
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Female