MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TRAY FOLEY LTX 16FR 10ML UM MF

Catalog Number	DYND150216S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Distress (2329)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, on 8/12 "the indwelling urinary catheter placed in 87 year old male patient.Upon entrance into the bladder, urine stream was noted to be spraying out of a previously not visible pinhole in the catheter itself.It was discovered upon insertion of the catheter.There was no injuries.The foley was removed and needed to be replaced with a new product immediately upon noting the problem.No injuries occurred from the event, although it was distressing for the patient to have a second insertion procedure immediately after the first".It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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
According to the facility, on 8/12 "the indwelling urinary catheter placed in 87 year old male patient.Upon entrance into the bladder, urine stream was noted to be spraying out of a previously not visible pinhole in the catheter itself.".

• Common Device Name: TRAY FOLEY LTX 16FR 10ML UM MF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20371256
• Report Number: 1417592-2024-00884
• Device Sequence Number: 12482186
• Product Code: PPB
• UDI-Device Identifier: 40195327387366
• UDI-Public: 40195327387366
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

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?: No
• Device Catalogue Number: DYND150216S
• Device Lot Number: 24CBQ086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Male