MAUDE Adverse Event Report: BECTON DICKINSON INTERLINK EXT 1 ADAPTER LINE

Catalog Number 2N3374-ZBA

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that leaked occurred from the interlink ext 1 adapter line connection.

Event Description

It was reported that leaked occurred from the interlink ext 1 adapter line connection.

Manufacturer Narrative

Investigation: the actual item returned was not connected to the injection site, the other company's refill kit was connected to the male lure.About the male lure we conducted a liquid leak test of iso 594-2, but we could not confirm the leak.Air pressure (55 kpa) was added after connecting the male lure to the refill kit manufactured by another company and a pressurization test was conducted in water.As a result, air leakage was recognized from the connecting part.No abnormality related to this event was found in the manufacturing process of this lot.Up to now, there were no other similar event reports in the lot concerned.In the analysis result, leakage was not recognized with only the actual male lure, leakage occurred when connecting with other company's products, so it is considered that there was no abnormality in the product.A dhr could not be performed as the lot# is unknown.

• Brand Name: INTERLINK EXT 1 ADAPTER LINE
• Type of Device: ADAPTER LINE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8206874
• MDR Text Key: 131908971
• Report Number: 2243072-2018-01870
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2N3374-ZBA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other