MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION NS 500 ML BAGS; SET, I.V. FLUID TRANSFER

Model Number 2B1323Q

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/15/2022

Event Type  No Answer Provided  

Event Description

Pediatric pharmacy staff noticed ns 500 ml iv bag do not have barcodes.Manufacturer response for iv bag, ns 500 ml bags (per site reporter) [redacted date] pharmacy stated they were going to enter an rl.This was reported to medline ([redacted name]) and baxter (pharmacy).Baxter (b)(4) [redacted date] [redacted name] requested baxter send another rma as they had sent the original to [redacted name] at another site.She provided baxter with the address for [redacted name] in pharmacy.No other bags except the ones reported in this incident were found to be affected, even those in the same lot# 462375.

• Brand Name: NS 500 ML BAGS
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 16111808
• MDR Text Key: 306795684
• Report Number: 16111808
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 2B1323Q
• Device Lot Number: Y403641
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1