MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTL1LYR 16FR10ML 100%SIL UM SAFESECURE

Catalog Number URO170816Q

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that on (b)(6) 2020, patient arrived to the emergency department with an indwelling catheter (chronic use) that required a change.Reporting nurse removed catheter, and attempted to insert a 16 fr.Silicone foley catheter (uro170816q).It was reported there was difficulty with insertion, slight bloody discharge from the meatus of the penis and no urine output.The silicone foley was successfully removed without difficulty.Reporting nurse states, a latex foley catheter was inserted without difficulty.No additional information is available at this time.There was no further intervention reported related to the incident.The sample is not available for returned and evaluation therefore, a definitive root cause could not be determined at this time.Due to the reported incident and the medical intervention required, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported a silicone foley catheter was inserted with difficulty with no urine output and slight bloody discharge from the meatus of the penis.That foley was successfully removed and a latex foley was inserted without difficulty.

• Type of Device: TTL1LYR 16FR10ML 100%SIL UM SAFESECURE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 10064048
• MDR Text Key: 205118403
• Report Number: 1417592-2020-00041
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 05/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: URO170816Q
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 79