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 Type  malfunction  

Manufacturer Narrative

First name: (b)(6).Initial reporter address: initial reporter postal code: should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the packaging of an unspecified quantity of solution sets were damaged (torn).The issue was identified before patient use.There was no patient involvement.No additional infomraiton is available.

Manufacturer Narrative

Additional information was added to d9, h3, h4, h6 and h10.H10: the device was received for evaluation.Visual inspection was performed which observed a damaged on the packaging.The reported condition was verified.The cause of the condition could not be determined.Meanwhile, ten (10) retained samples were visually inspected and no issues were found.The reported condition was not verified in the retained samples.A nonconformance has been opened to address this issue.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 ; 2242702068
• MDR Report Key: 14735401
• MDR Text Key: 294674551
• Report Number: 1416980-2022-03176
• 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: NA
• 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: 07/08/2022

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
• Device Operator: Other
• Device Catalogue Number: ABM9830L
• Device Lot Number: 56CLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• 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