MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	1A8504
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two (2) 1000ml evacuated containers were found damaged (cracked glass).This was observed before use.The shipping box was in good condition.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The devices were not received for evaluation; however a photograph was provided which showed a cracked bottle inside the shipping box.A distribution review was performed on the order with no issues noted during shipment of the product.The reported condition was identified.The cause of the damage could not be determined; however may be due to shipping activities after the product left the warehouse.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NA
• Common Device Name: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CLEVELAND; 911 north davis; cleveland MS 38732
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22740831
• Report Number: 1416980-2025-04086
• Device Sequence Number: 20632749
• Product Code: GCY
• UDI-Device Identifier: 00085412046167
• UDI-Public: (01)00085412046167(10)G177313(17)260430
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

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: Other
• Device Expiration Date: 04/30/2026
• Device Model Number: 1A8504
• Device Catalogue Number: 1A8504
• Device Lot Number: G177313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 08/07/2025
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown