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

Catalog Number	DYNJ69556B
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2024 the cesarean section drape had a "separation between its plastic and paper components as the baby was delivered".
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 the cesarean section drape had a "separation between its plastic and paper components as the baby was delivered".The customer reported due to the reported issue the "amniotic fluid and blood leaked down the bed".The customer reported due to the incident "compromising the integrity of the sterile field", prophylactic antibiotics were administered to the patient.The customer did not report any serious injury 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 2753
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 20477572
• Report Number: 1423395-2024-00492
• Device Sequence Number: 8330736
• Product Code: OHM
• UDI-Device Identifier: 40195327242511
• UDI-Public: 40195327242511
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ69556B
• Device Lot Number: 24GBE758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/17/2024
• 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