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

Catalog Number DYNC1820

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Infection (1930)

Event Date 05/25/2015

Event Type  Injury  

Manufacturer Narrative

An inmate and his sister both reported that while being incarcerated in a state prison, he was admitted to a hospital for an infection in his right testicle.The inmate alleges the prison's policy is to reuse the same catheter for 3 days.It is not known how many times it was reused during the 3 day period.There is no sample for evaluation.The device label indicates single use only.The catheter is a sterile device and is not intended to be reused.The root cause for the reported infection has not been confirmed, however we cannot rule out misuse as the cause.

Event Description

An inmate states that while being incarcerated in a state prison, he suffered an infection in his right testicle due to misuse of a foley catheter.He was subsequently hospitalized.

• Type of Device: FOLEY CATHETER
• 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: 5733384
• MDR Text Key: 47697802
• Report Number: 1417592-2016-00064
• 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: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: DYNC1820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR