MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; ETHOX 4030 INFU-SU 3000ML PRESSURE IN

Model Number	950089904
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportable as it was an interruption in therapy for the patient.
Event or Problem Description
Bag exploded while it was being pumped up.
Additional Manufacturer Narrative
Reportable as it was an interruption in therapy for the patient.The complaint of "bag exploded while it was being pumped up" were reported.There were no photo images or videos provided for evaluation.However, potential root cause of the issue may have been caused by inadequate seal over inflation that would cause the bag seal to pop open or seams to tear.Testing was performed for inventory analysis for lot number 230600719 that was pulled closest to the lot number provided.Based on the test results the defect was not confirmed in the inventory analysis for lot number 230600719 that was pulled closest to the lot number provided.All units were observed to not have any visible damage.The regulatory risk was identified as minor-violative per table 2 of ref-(b)(4) and has been submitted to carb for review.We will continue to monitor trends during our periodic complaint review meetings.
Event or Problem Description
Bag exploded while it was being pumped up.

• Brand Name: SUNMED LLC
• Common Device Name: ETHOX 4030 INFU-SU 3000ML PRESSURE IN
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18008509
• Report Number: 1314417-2023-00024
• Device Sequence Number: 7478354
• Product Code: KZD
• UDI-Device Identifier: 20889483149826
• UDI-Public: 20889483149826
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 950089904
• Device Catalogue Number: 950089904
• Device Lot Number: 230100490
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown