MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number ABM9830L

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter last name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a perforation in the sterile packaging of a exaset solution set.The damaged packaging was identified during the receipt of the product prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, ten (10) retained samples and two (2) photographs of the actual sample were evaluated.Visual inspection of the photographs was performed which identified the primary packaging was opened and damaged (tear).A visual inspection was performed on the retained samples and no defects were found that could have contributed to the reported condition; the samples were intact and met specifications.The reported condition was verified on the photographs of the actual sample; however, not verified on the retained samples.The cause of the damaged packaging was related to the storage/distribution 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: SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - ATLACOMULCO; av. ing. salvador sanchez; colin no. 9; atlacomulco CP 50 450; MX CP 50450
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18935109
• MDR Text Key: 338314313
• Report Number: 1416980-2024-01212
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412353234
• UDI-Public: (01)00085412353234
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: ABM9830L
• Device Lot Number: 14EBE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1