MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC; FOLEY CATHETER

Catalog Number DYND160714

Device Problem Detachment Of Device Component (1104)

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

Event Date 01/06/2016

Event Type  Injury  

Manufacturer Narrative

When removing syringe after balloon inflation, the inflation valve became separated and stayed attached to the syringe.Minimal details were provided regarding this incident.The contact did not know if the catheter was removed or replaced as a result of this incident.It is not known if the valve separation resulted in the balloon deflating.If it did, the catheter could have fallen out.The facility confirmed that no patient injury resulted.No sample was returned for evaluation.We have not confirmed the issue or identified a root cause.Device not returned.

Event Description

After insertion of a foley catheter the inflation valve separated.

• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline place; mundelein IL 60060
• Manufacturer Contact: megan debus ; one medline place; mundelein, IL 60060 ; 8477703962
• MDR Report Key: 6132825
• MDR Text Key: 61083818
• Report Number: 1417592-2016-00120
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: DYND160714
• Device Lot Number: 15YB1052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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