MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. EXACTAMIX INLET NON-VENTED, HIGH-VOLUME INLET SET, I.V. FLUID TRANSFER

Lot Number 802523

Device Problems Cap (424); Material Puncture/Hole (1504); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2018

Event Type  Malfunction  

Event Description

Pharmacy tech retrieved baxter exactamix inlet non-vented, high volume inlet, ref: (b)(4), lot: 802523, exp: 12/04/2020. The spike had no cap and pierce the packaging.

• Brand Name: EXACTAMIX INLET NON-VENTED, HIGH-VOLUME INLET
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 8129259
• MDR Text Key: 129435365
• Report Number: MW5081818
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: PHARMACIST
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/03/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device EXPIRATION Date: 12/04/2020
• Device LOT Number: 802523
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated By Manufacturer?

Is The Device Single Use?

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage