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

Catalog Number	DYND160816T
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the sample port "came fully out of the foley catheter.After putting it back in, it was noted to be loose and easily would come out of the plastic tubing.So i removed it and replaced it again with a new temp foley.I tried to use the sample port, it came fully out of the foley catheter.After putting it back in, it was noted to be loose and easily would come out of the plastic tubing.So i removed it and replaced it again with a new temp foley".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 or Problem Description
Sample port became dislodged.

• Common Device Name: 1LYR 16FR10ML 100%SIL TMP TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19355521
• Report Number: 1417592-2024-00609
• Device Sequence Number: 7466142
• Product Code: OHR
• UDI-Device Identifier: 10884389123119
• UDI-Public: 10884389123119
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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: DYND160816T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown