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

Catalog Number 1C8333

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an interlink blood bag spike had its spike detach from the rubber septum.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The actual device was not available; however, a companion sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing, pressure testing, and clear passage testing were performed with no issues noted.The reported condition was not verified.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: ACCESS
• 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5087343
• MDR Text Key: 26163165
• Report Number: 1416980-2015-36471
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/13/2019
• Device Catalogue Number: 1C8333
• Device Lot Number: R14L13052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• 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