MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; NEPHROLOGY PACK

Catalog Number	DYNJ63200C
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on multiple dates for multiple patients, "the interventional nephrology team completed a procedure and when they discarded the sterile table, they noticed the metal roll around table was soaking wet.This occurs at the end of the procedures.This means the liquid was able to soak through and contaminates from the metal table could have also soaked through.The physician gave the patient antibiotics after the procedure due to this faulty table cover.The patients were exposed to whatever could've soaked through the drape and they had to receive antibiotic.The procedures were completed".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
According to the facility on multiple dates for multiple patients, "the interventional nephrology team completed a procedure and when they discarded the sterile table, they noticed the metal roll around table was soaking wet.".

• Common Device Name: NEPHROLOGY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20257258
• Report Number: 1423395-2024-00480
• Device Sequence Number: 20769146
• Product Code: LRO
• UDI-Device Identifier: 40195327675302
• UDI-Public: 40195327675302
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/19/2024

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: DYNJ63200C
• Device Lot Number: 24CBS557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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