MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD VENTED MICRO VOL.INLET, N/S; SET, I.V. FLUID TRANSFER

Catalog Number H938175

Device Problem Filling Problem (1233)

Patient Problem No Patient Involvement (2645)

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a vented micro-volume inlet underdelivered during compounding.The reporter stated that the device had an underdelivery of over 10% (not further specified).The device was being used with a bottle of 30% sodium chloride solution.The reporter indicated that the underdelivery had been identified by weighing the bottle.The reporter stated that the set had no visible defects, and that the compounded bags were not provided to patients.There was no patient involvement.No additional is available.

• Brand Name: VENTED MICRO VOL.INLET, N/S
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE - ENGLEWOOD; englewood CO
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7238919
• MDR Text Key: 99094699
• Report Number: 1416980-2018-00529
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938175
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1