MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; 1LYR 16FR10ML 100%SIL TMP TRAY

Model Number	DYND160816T
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the end-user had the foley catheter placed on (b)(6) 2020 at 8:05am and at approximately 9:50am it was noted that the tip of the catheter was visualized through the bladder wall.The client was scheduled for a lap assisted hysterectomy and while advancing the tip of the catheter the tip went through the bladder wall resulting in an additional repair to the bladder.The surgery scheduled as a laparoscopy assisted vaginal hysterectomy (lavh) turned into a laparotomy with cystotomy repair.According to the facility the patient is continuing with the foley catheter and underwent a cystogram on (b)(6) 2020 without evidence of contrast extravasation.The patient continues to follow up with a urologist.The sample was returned to the manufacturer for evaluation; however no manufacturing defect could be determined.No additional information is available.Due to the reported incident and in an abundance of caution, this is an mdr reportable event.If any further relevant information is identified or obtained, this report will be reopened and re-evaluated.
Event or Problem Description
It was reported that the tip of catheter penetrated the bladder wall requiring surgical intervention.

• Brand Name: MEDLINE
• Common Device Name: 1LYR 16FR10ML 100%SIL TMP TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11100366
• Report Number: 1417592-2020-00162
• Device Sequence Number: 4088861
• Product Code: OHR
• UDI-Device Identifier: 10884389123119
• UDI-Public: 10884389123119
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/31/2020

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 Model Number: DYND160816T
• Device Catalogue Number: DYND160816T
• Device Lot Number: 20EBK362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/31/2020
• 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