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

Catalog Number 1C8740

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a non-dehp microvolume filter extension set leaked due to a hole in the filter during an unspecified diuretic administration.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.During visual inspection, the membrane of the y-site part was observed to be displaced.Pressure testing was performed and a leak was observed in the y-site through the membrane port.No leaks were observed due to a hole in the filter.Upon closer inspection, a needle was used through the membrane port.The reported condition was verified.The cause of the condition was due to the end user.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: INTERLINK MICRO-VOLUME EXTENSION SET
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina san cristobal
• MDR Report Key: 8881112
• MDR Text Key: 153949709
• Report Number: 1416980-2019-04365
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• PMA/PMN Number: K113227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

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: Health Professional
• Device Catalogue Number: 1C8740
• Device Lot Number: DR18F11095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 08/23/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DIURETIC