MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE

Catalog Number 2N3350

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 a micro-volume extension set leaked from a crack in the filter.This occurred during infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional leak testing revealed a leak from the vent hole of the filter.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MICRO-VOLUME EXTENSION SET
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL; parque industrial itabo, zona; haina ; DR
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL; parque industrial itabo, zona; haina ; DR
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5595381
• MDR Text Key: 43278399
• Report Number: 1416980-2016-07656
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

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: No Information
• Device Catalogue Number: 2N3350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2016
• 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