MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYR 16FR10ML 100%SIL TMP SAFE

Catalog Number URO170816TQ

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/03/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer on (b)(6) 2022 a foley catheter was placed for hemodynamic monitoring and urinary retention.Per the facility when the patient was repositioned the foley catheter tubing slid out of the urethra requiring an additional catheter to be placed.Per the facility there was no additional medical intervention or serious injury noted in relation to the reported incident.The sample was returned for evaluation and the issue confirmed, however, a definitive root cause could not be determined at this time.No additional information is available at this time.Due to the reported incident and 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 Description

According to the customer on (b)(6) 2022 a foley catheter was placed for hemodynamic monitoring and urinary retention.Per the facility when the patient was repositioned the foley catheter tubing slid out of the urethra requiring an additional catheter to be placed.

• Type of Device: 1LYR 16FR10ML 100%SIL TMP SAFE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15853707
• MDR Text Key: 304204834
• Report Number: 1417592-2022-00227
• Device Sequence Number: 1
• Product Code: OHR
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: URO170816TQ
• Device Lot Number: 22FBW904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other