MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TTL1LYR 16FR10ML 100%SILI DB TRA

Catalog Number	URO170716
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer on 3/19, "the foley was inserted into the female patient and the rn used the enclosed syringe with 10ml sterile water to inflate the balloon.The surgeon needed to perform a cystoscopy, so she deflated the balloon and removed the catheter.During the cystoscope, the surgeon noticed a foreign body floating in the bladder.Further visualization caused the surgical team to suspect it was a piece of the foley catheter.The foley catheter was inspected and found to be missing just the balloon".The customer also reported that "the surgeon spent a considerable amount of time trying to retrieve the piece and eventually asked to have a urologist consulted to assist her.During the process of contacting a urologist that was available to come in that moment, the surgeon was able to grasp the piece with a grasper and removed it".The sample is available for evaluation.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 customer on 3/19, "the foley was inserted into the female patient and the rn used the enclosed syringe with 10ml sterile water to inflate the balloon.The surgeon needed to perform a cystoscopy, so she deflated the balloon and removed the catheter.During the cystoscope, the surgeon noticed a foreign body floating in the bladder.

• Common Device Name: TTL1LYR 16FR10ML 100%SILI DB TRA
• 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: 19114752
• Report Number: 1417592-2024-00505
• Device Sequence Number: 7102882
• Product Code: LRO
• UDI-Device Identifier: 40888277866912
• UDI-Public: 40888277866912
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/16/2024

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: URO170716
• Device Lot Number: 24ABL500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown