MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; FOLEY CATHETER, SILICONE, 16FR

Catalog Number DYND160716

Device Problem Deflation Problem (1149)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

A catheter was inserted in the sicu, there were no difficulties with insertion reported.The next morning staff were unable to deflate catheter balloon and remove catheter.Staff attempted multiple methods to remove catheter with no success.Successful removal required urology to place a wire into the catheter and manually rupture the balloon.No patient injury or additional intervention required.The sample was not returned for evaluation.A root cause has not been determined.No photos where received.Due to reported incident a medwatch is being filed.

Event Description

Foley catheter balloon would not deflate requiring intervention.

• Type of Device: FOLEY CATHETER, SILICONE, 16FR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 5900030
• MDR Text Key: 52864243
• Report Number: 1417592-2016-00087
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: DYND160716
• Device Lot Number: 16QB4513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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
• Patient Outcome(s): Other; Required Intervention