MAUDE Adverse Event Report: BAXTER HEALTHCARE - IRVINE INFUSOR; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2C1009KP

Device Problems Leak/Splash (1354); Chemical Spillage (2894)

Patient Problem No Patient Involvement (2645)

Event Date 07/03/2014

Event Type  malfunction  

Event Description

It was reported that an infusor elastomeric device leaked approximately 2mls before use.The leak was noted upon unpacking the device, where it had leaked into the over-pouch.The reporter stated that they did not notice any issues with the packaging and did not know the source of the leak.The device was filled with 4400 mg of fluorouracil.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).A request for the return of the device has been made.Upon completion of baxter's investigation, if additional relevant information is obtained, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was manufactured between april 18, 2014 - april 19, 2014.Evaluation summary: baxter received the unit for evaluation with fluid in the packaging.Visual inspection identified an untightened blue winged luer cap.A functional leak test was performed, the blue winged cap was tightened, and the unit was monitored.The next day, no signs of leak were observed at the blue winged luer cap.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: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue, bldg 3; irvine CA 92614
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue, bldg 3; irvine CA 92614
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3961780
• MDR Text Key: 4559904
• Report Number: 1416980-2014-24465
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2014

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: 04/01/2017
• Device Catalogue Number: 2C1009KP
• Device Lot Number: 14D031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2014
• Initial Date FDA Received: 07/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/31/2014
• 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: Unknown
• Patient Sequence Number: 1