MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; C-SECTION PACK

Catalog Number	DYNJ19417R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2025 during irrigation the "beak of the pitcher came off the pitcher and fell into the patient's peritoneal cavity".
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 during irrigation the "beak of the pitcher came off the pitcher and fell into the patient's peritoneal cavity".The customer reported they were able to retrieve the piece of the broken pitcher after the incident occurred.The customer reported the procedure was able to be completed.The customer did not report any serious injury, medical intervention, or follow up care related to the reported event.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 again.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.

• Common Device Name: C-SECTION PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21375226
• Report Number: 1423395-2025-00012
• Device Sequence Number: 3849366
• Product Code: OHM
• UDI-Device Identifier: 10195327351373
• UDI-Public: 10195327351373
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/13/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ19417R
• Device Lot Number: 24IMI839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 28 YR
• Patient Sex: Female
• Patient Weight: 94 KG