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

Catalog 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
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of 1000ml evacuated containers were broken inside the shipping container.The shipping box contained 6 glass bottles and one was broken upon arrival to the.This was observed prior to use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Correction to b5: add: broken upon arrival to the ¿customer¿ (missing the word customer on intital).H10: the actual devices were not available; however, photographs of the samples were provided for evaluation.Visual inspection was performed to the photographs which observed a damaged bottle in one of the returned photos.The reported condition was verified.The cause of the condition was due to the shipping/delivery process.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EVACUATED CONTAINER
• 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: 16159840
• Report Number: 1416980-2022-07396
• Device Sequence Number: 15321051
• Product Code: GCY
• UDI-Device Identifier: 00085412046167
• UDI-Public: (01)00085412046167
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 1A8504
• Device Lot Number: G158855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2022
• 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