MAUDE Adverse Event Report: TELEFLEX INCORPORATED RUSCH PEDIATRIC FOLEY CATHETER 6 FR.; CATHETER, RETENTION TYPE, BALLOON

Lot Number KME21K1383

Device Problem Material Perforation (2205)

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

Event Date 05/27/2022

Event Type  malfunction  

Event Description

Pediatric patient with foreign object in nose.Provider used rusch pediatric foley catheter to remove foreign object from nose.Upon removing the catheter from the nose, the physician reported the stylet had punctured the catheter and was sticking out of the side of the catheter.No injury to the patient was identified.

• Brand Name: RUSCH PEDIATRIC FOLEY CATHETER 6 FR.
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 15264742
• MDR Text Key: 298306424
• Report Number: 15264742
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: KME21K1383
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1095 DA