INTERLINK MICRO-VOLUME EXTENSION SET 1C8740

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for INTERLINK MICRO-VOLUME EXTENSION SET 1C8740 manufactured by Baxter Healthcare - Cleveland.

Event Text Entries

[125703871] Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10

[125703872] This report summarizes 1 malfunction events. It was reported that one interlink minivolume extension set was? Defective?. This occurred during an unspecified process step. It is unknown if a patient was involved in the event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5

[134619150] Additional information: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10

[134619151]
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1416980-2018-06961
• MDR Report Key: 8021230
• Date Received: 2018-10-30
• Date of Report: 2019-01-30
• Date Mfgr Received: 2018-12-31
• Date Added to Maude: 2018-10-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 25212 W. ILLINOIS ROUTE 120
• Manufacturer City: ROUND LAKE IL 60073
• Manufacturer Country: US
• Manufacturer Postal: 60073
• Manufacturer Phone: 2242702068
• Manufacturer G1: BAXTER HEALTHCARE - CLEVELAND
• Manufacturer Street: 911 HIGHWAY 61 NORTH PO BOX 1058
• Manufacturer City: CLEVELAND MS 38732
• Manufacturer Country: US
• Manufacturer Postal Code: 38732
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: INTERLINK MICRO-VOLUME EXTENSION SET
• Generic Name: FILTER, INFUSION LINE
• Product Code: FPB
• Date Received: 2018-10-30
• Model Number: NA
• Catalog Number: 1C8740
• Lot Number: ASKU
• Device Availability: *
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAXTER HEALTHCARE - CLEVELAND
• Manufacturer Address: CLEVELAND MS

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-10-30