MAUDE Adverse Event Report: TELEFLEX INCORPORATED RUSCH; CATHETER, RETENTION TYPE, BALLOON

Model Number IPN050125

Device Problems Inflation Problem (1310); Leak/Splash (1354); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2017

Event Type  malfunction  

Event Description

During placement of this child's foley catheter it was discovered that the balloons on the size 6's were faulty.The balloons would inflate but then when checked to make sure balloon was secure the foley could be pulled out.The balloon was checked and found to be leaking.Attempted foley insertion two more times with each catheter also leaking and balloon not staying inflated.A fourth catheter size 8 french was then used and secured without difficulty.All three catheters were placed in urine cups, labeled and given to charge nurse and all other size 6 french catheters were removed from the pediatric unit.

• Brand Name: RUSCH
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville rd.; reading PA 19605
• MDR Report Key: 6460086
• MDR Text Key: 71719366
• Report Number: 6460086
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2017,03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/31/2021
• Device Model Number: IPN050125
• Device Catalogue Number: 170003060
• Device Lot Number: 16DE18
• Other Device ID Number: (01) 04026704020010 (17) 2103
• 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: 02/28/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Age: 1 YR