MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYRTR 16FR10ML100% SILTMP SNP

Catalog Number URO175816T

Device Problem Material Integrity Problem (2978)

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

Event Date 07/12/2023

Event Type  Injury  

Manufacturer Narrative

According to the facility on 07/12/2023 "a nurse took a sample with a syringe from the sampling port and the blue piece in the middle fell of when the syringe was pulled".Per the facility "the catheter needed to be replaced because it opened up the catheter port".Sample requested to be returned for evaluation.No additional information is available at this time.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 Description

According to the facility on 07/12/2023 "a nurse took a sample with a syringe from the sampling port and the blue piece in the middle fell of when the syringe was pulled".

• Type of Device: 1LYRTR 16FR10ML100% SILTMP SNP
• 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: 17470789
• MDR Text Key: 320507553
• Report Number: 1417592-2023-00329
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10193489988505
• UDI-Public: 10193489988505
• 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: 08/07/2023

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: URO175816T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 08/07/2023
• 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