MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; MAJOR LAPAROTOMY II

Catalog Number	DYNJS3018
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer on (b)(6) 2024, "it was an exploratory laparotomy with revision loop ileostomy case; the belly was open with bowel exposed.While waiting for an assisting surgeon to arrive the blue towels from the pack were moistened with sterile normal saline and placed over the open belly.After surgeon removed blue towel and saw blue lint-surgeon immediately and vigorously irrigated the open abdomen, then manually removed the remaining lint.It is not known at this time if there was any impact to the patient.It caused surgeon delay as she had to irrigate vigorously and then pick off the remaining lint".A sample from the same lot is available for evaluation.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 customer on (b)(6) 2024, "it was an exploratory laparotomy with revision loop ileostomy case; the belly was open with bowel exposed.While waiting for an assisting surgeon to arrive the blue towels from the pack were moistened with sterile normal saline and placed over the open belly.After surgeon removed blue towel and saw blue lint-surgeon immediately and vigorously irrigated the open abdomen, then manually removed the remaining lint.".

• Common Device Name: MAJOR LAPAROTOMY II
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; 2249317042
• MDR Report Key: 19404687
• Report Number: 1423395-2024-00418
• Device Sequence Number: 12501643
• Product Code: FDE
• UDI-Device Identifier: 40884389099583
• UDI-Public: 40884389099583
• Combination Product (Y/N): N
• 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): 05/28/2024

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: DYNJS3018
• Device Lot Number: 23ISO036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/28/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown