MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; 1LYR 18FR 10ML SILVER UM TRAY

Catalog Number	DYND160518H
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the foley catheter broke off inside the patient resulting in this patient requiring surgery (cystoscopy without incisions) and re-insertion of new foley catheter.The foley catheter was indicated for the patient's urinary retention/bladder obstruction and was in place 3 days prior to the incident.The foley catheter broke 2-3 inches from the tip and on surgeon's evaluation of the patient, there was no damage to the bladder, urethra, or prostate.Of note, it was reported that at the time the catheter break was discovered, the patient had an unwitnessed fall.Patient has been discharged for his original hospital admission issue and no further issues were reported.The sample has been returned for evaluation and the customer reported issue of a torn catheter was confirmed.A root cause cannot be determined at this time.Due to the reported incident and need for surgical intervention, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the foley catheter broke off inside the patient requiring surgery and re-insertion of new foley catheter.

• Common Device Name: 1LYR 18FR 10ML SILVER UM TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7295752
• Report Number: 1417592-2018-00009
• Device Sequence Number: 1354936
• Product Code: OHR
• UDI-Device Identifier: 10884389287743
• UDI-Public: 10884389287743
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/26/2018

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: Physician
• Device Catalogue Number: DYND160518H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 02/26/2018
• 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: 80 YR
• Patient Weight: 63