MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD TUBE SET, STD VOL, STER; SET, I.V. FLUID TRANSFER

Catalog Number H93811

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The reported event occurred sometime in 2016.The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a repeater pump tube set had a hair inside the un-opened packaging.This was discovered prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation in its unopened packaging.Visual inspection revealed a short brown hair inside the package.The reported condition was verified.The cause of the condition was determined to be a manufacturing issue.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: TUBE SET, STD VOL, STER
• 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: 6133408
• MDR Text Key: 61084692
• Report Number: 1416980-2016-17747
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K900585
• 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,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H93811
• Device Lot Number: 1151471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2017
• 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