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

Model Number	1A8504
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the lot number (10) and subsequent expiration date (17) are unknown; therefore, the udi number only will contain the device identifier (01).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of 1000 ml evacuated containers were broken.This issue was further described as, ¿1 case was broken¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h6 and h11.Correction: b5, previous g3: date received by mfr (should be 12/24/2024).B5: replace "there was no report of patient injury or medical intervention associated with this event." to "there was no patient involvement.".H11: the devices were not returned and the lot number is unknown; however, a distribution review was performed using the product order number as product was received broken by customer.The distribution review did not identify any issues with distribution of this order from baxter's distribution center.All inspections performed during distribution activities up until the carrier took possession were found acceptable.Therefore, the cause of the damage was due to further handling by a third party during shipment.Handling procedures during shipment with third party distributors require more manual manipulation as these shipments are generally comprised of smaller orders that are not shipped in a palletized configuration.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 highway 61 north; po box 1058; cleveland MS 38732
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21179530
• Report Number: 1416980-2025-00096
• Device Sequence Number: 18293381
• Product Code: GCY
• UDI-Device Identifier: 00085412046167
• UDI-Public: (01)00085412046167
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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 Model Number: 1A8504
• Device Catalogue Number: 1A8504
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/21/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown