INTERLINK * 2N3339

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-12 for INTERLINK * 2N3339 manufactured by Baxter Healthcare.

Event Text Entries

[5571580] While attempting to insert a micro-draw blood transfer device into a t-connector iv extension set, the user could not pierce the septum of the extension set. Several attempts were needed to accomplish insertion. The clinician noted that the blood transfer device utilized a flat blunt insertion needle that specified the extension set by reference number. The clinician attempted additional insertions with additional devices with no success. A sample device sent to our biomed engineering department for analysis and returned to the manufacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4620935
• MDR Report Key: 4620935
• Date Received: 2015-02-12
• Date of Report: 2015-02-12
• Date of Event: 2015-01-15
• Report Date: 2015-02-12
• Date Reported to FDA: 2015-02-12
• Date Reported to Mfgr: 2015-03-20
• Date Added to Maude: 2015-03-20
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: INTERLINK
• Generic Name: IV SET
• Product Code: FPA
• Date Received: 2015-02-12
• Model Number: *
• Catalog Number: 2N3339
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Device Age: 1 DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAXTER HEALTHCARE
• Manufacturer Address: ONE BAXTER PARKWAY WESTLAKE VILLAGE CA 91362 US 91362

Device Sequence Number: 2

• Brand Name: HUMMI MICRO-DRAW
• Generic Name: BLOOD TRANSFER DEVICE
• Product Code: KST
• Date Received: 2015-02-12
• Model Number: ABG-HM-1
• Catalog Number: ABG-HM-1
• Lot Number: 201440603
• ID Number: *
• Device Availability: Y
• Device Age: 1 DAY
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: HUMMINGBIRD MED
• Manufacturer Address: 2797 PRADO LN MARIETTA GA 30066 US 30066

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-02-12