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

Catalog Number J2C1711

Device Problem Scratched Material (3020)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there were scratch marks on the bladder of a small volume infusor.This was noted during filling.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was manufactured october 7, 2017 - october 9, 2017.The device was received for evaluation with approximately 100ml of fluid in its bladder.Visual inspection revealed white blooming marks (in the shape of small lines) located on the outer surface of the inflated bladder.Infrared spectroscopy revealed that the marks were made of antioxidant.These are not scratch marks.Antioxidant is a component of the bladder material.Antioxidant does not affect the functionality or safety of the device.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, ELASROMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; irvine CA
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7670162
• MDR Text Key: 113429264
• Report Number: 1416980-2018-04194
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412092706
• UDI-Public: (01)00085412092706
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: J2C1711
• Device Lot Number: 17K008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2018
• 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