MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC; SILICONE FOLEY CATHETER

Catalog Number URO170816S

Device Problem Deflation Problem (1149)

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

Event Type  Injury  

Manufacturer Narrative

Patient had a 16 french foley catheter placed in the emergency department (ed), for urine retention, and was discharged home.Catheter remained in place for three days when the balloon deflated and the catheter fell out.The patient returned to the ed and an 18 french foley catheter was placed and patient was discharged home.Patient returned to ed a third and fourth time with the same complaint.Each time an 18 french catheter was re-placed and patient was discharged home.No complications with the fourth foley catheter have been reported.Per the clinical director of the emergency department there were no complications with the insertions of the catheters and balloon integrity was not tested prior to any insertion.Two samples were returned and showed tears in the balloons, a root cause for the tears has not been determined.Due to the multiple foley catheter insertions this medwatch is being filed.

Event Description

A patient had to have multiple foley catheters inserted due to balloons deflating.

• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline place; mundelein IL 60060
• Manufacturer Contact: megan debus ; one medline place; mundelein, IL 60060 ; 8476433962
• MDR Report Key: 6072254
• MDR Text Key: 58931778
• Report Number: 1417592-2016-00116
• 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: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: URO170816S
• Device Lot Number: 16SB0626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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