MINI-BAG PLUS (MBP)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-03 for MINI-BAG PLUS (MBP) manufactured by Baxter Healthcare Corporation.

Event Text Entries

[129435315] To ensure medication safety, it is important that medications be scanned properly prior to administration. However, the barcodes on mini-bag plus (mbp) and add-vantage ivpbs have caused an issue with this process at (b)(6) hospital. Appropriate barcode scanning by nurses administering these preparations require the scanning of both the drug vial and the ivpb bag. The ivpb bags have a white barcode that makes it difficult for nurses to scan if a pt label is present on the other side. As a result, a medication scan override occurs and the medication ends up not being properly scanned. For example, an analysis was conducted to determine the number of ampicillin 2 g in ns 100 ml mbp bags dispensed over a 24 hour period; 33 bags were dispensed in total; however, 25 bags had at least one component (ampicillin or ns) not scanned. Of the 25 not scanned, 18 were attributed to the ns, 9 of them due to the barcode being unreadable. To fix this issue, the pt label is to be placed sideways on the product or flagged in order for the barcode to be scanned. Although this alteration allows for proper barcode scanning, it is merely a temporary fix. Ultimately, it would be beneficial for the mfr to change the color of the barcode from white to black. This would allow for the pt label to be properly placed on the opposite side while the barcode would now able to be scanned, ensuring the correct medication is going to the right pt. Medication administered to or used by the pt: no. Ismp, (b)(6) access number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5081788
• MDR Report Key: 8128826
• Date Received: 2018-12-03
• Date of Report: 2018-10-24
• Date Added to Maude: 2018-12-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: MINI-BAG PLUS (MBP)
• Generic Name: EQUIPMENT LOBORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICA
• Product Code: LXG
• Date Received: 2018-12-03
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAXTER HEALTHCARE CORPORATION

Device Sequence Number: 2

• Brand Name: ADD-VANTAGE IVPBS
• Generic Name: SET, I.V. FLUID TRANSFER
• Product Code: LHI
• Date Received: 2018-12-03
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-12-03