MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE

Catalog Number 2N3350

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This event occurred on an unspecified date in (b)(6) 2019.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified quantity of non-dehp extension set leaked at the filter.The event occurred during an infusion with an unspecified medication.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information : the device was returned for evaluation.A visual inspection was performed, and all components were correctly placed and according to specifications (no visual defect were observed).The sample was then functionally tested and primed, and it was determined that the device primed and flowed normally.Additionally, the filter was pressure tested with no issue noted.The reported condition was not verified.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 - DOMINICAN REPUBLIC; haina san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8960076
• MDR Text Key: 156449185
• Report Number: 1416980-2019-04791
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2N3350
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2019
• 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