MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD EXACTAMIX; DISPOSABLE; TUBE SET; SET, I.V. FLUID TRANSFER

Catalog Number H938174

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an exactamix set had contamination.The event was further described by the reporter as that a lock of hair was found in the overpouch.The event occurred before use; therefore, there was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection identified a small black fiber/hair inside the lower left quadrant of the overpouch.Microscopic examination revealed the particle to be a fiber.The reported condition was verified.The cause of the condition could not be determined.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: EXACTAMIX; DISPOSABLE; TUBE SET
• 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; ni; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6347657
• MDR Text Key: 67926564
• Report Number: 1416980-2017-01480
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: H938174
• Device Lot Number: 802076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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