MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRAY,FOLEY,CATH,SIL-ELAST,16FR,10ML,BG

Catalog Number	DYND11003H
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hospice facility associate, who reported that a (b)(6) female hospice patient with a medical history of multiple sclerosis and chronic obstructive pulmonary disease had a catheter balloon burst while the catheter was inserted.The patient had the catheter inserted for chronic medical issues on (b)(6) 2019 and on (b)(6) 2019 the balloon burst.The balloon was pre-inflated to check for integrity prior to insertion.The catheter was removed after the balloon burst to ensure noting remained in the patient and a new catheter was placed with no further intervention or incident noted.The sample is not available to be returned for evaluation.Per the facility, there was no serious injury or follow-up medical care required related to the incident, however medical intervention to replace the initial catheter was necessary.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
A female patient was had a foley catheter in place for one day and the balloon burst resulting in the catheter being removed and replaced with a new catheter.

• Common Device Name: TRAY,FOLEY,CATH,SIL-ELAST,16FR,10ML,BG
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8793209
• Report Number: 1417592-2019-00119
• Device Sequence Number: 2539987
• Product Code: OHR
• UDI-Device Identifier: 10080196991471
• UDI-Public: 10080196991471
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYND11003H
• Device Lot Number: 96919030002
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR