MAUDE Adverse Event Report: BAXTER HEALTHCARE IVT DISPOSABLE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number R2C0477

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

It was reported that sterile overpouch of an automix compounder transfer set was described to have been welded incorrectly.There was no patient involvement.Additional information was requested and is not available.

Manufacturer Narrative

(b)(4).The device was received for analysis and an evaluation has begun but has not yet been completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was received for evaluation.Visual inspection (via the naked eye) revealed that the upper part of the pouch was open.The reported condition was verified.A capa has been opened to address this 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: IVT DISPOSABLE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• Manufacturer (Section G): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4278141
• MDR Text Key: 5005704
• Report Number: 1416980-2014-42583
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2014

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 Expiration Date: 12/31/2017
• Device Catalogue Number: R2C0477
• Device Lot Number: R13A03080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2015
• Initial Date FDA Received: 11/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1