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

Catalog Number DYND160116

Device Problem Deflation Problem (1149)

Patient Problem No Information (3190)

Event Date 11/20/2015

Event Type  Injury  

Manufacturer Narrative

The catheter had been inserted to instill a chemo drug.The catheter was then clamped for two hours.When attempting to remove the catheter, the balloon would not deflate.They cut the catheter and inserted a guidewire through the inflation lumen and the balloon deflated.The catheter was removed without further incident.The catheter was not replaced.The integrity of the balloon was tested prior to use.No serious injury resulted and no additional medical intervention was necessary.The sample has not been returned for evaluation.A root cause has not been determined.

Event Description

The catheter balloon would not deflate.

• Type of Device: LATEX FOLEY CATHETER, 16FR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5285766
• MDR Text Key: 33249439
• Report Number: 1417592-2015-00113
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: DYND160116
• Device Lot Number: 15TB6303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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
• Patient Age: 90 YR
• Patient Weight: 72