MAUDE Adverse Event Report: BECTON DICKINSON, S.A. CONNECTOR LUER LOCK C45; INTRAVASCULAR ADMINISTRATION SET

Model Number 515202

Device Problem Infusion or Flow Problem (2964)

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

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the connector luer lock c45 experienced flow issues when used for infusion during use.The following information was provided by the initial reporter: material no: 515202, batch no: unknown.Event description: n35/c45 seemed to be clogged when starting infusion.The drug from secondary chemo bag was not pulling.Seemed like it was just pulling air.They changed n35 & c45 and everything worked fine.

Manufacturer Narrative

H.6.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.

Event Description

It was reported that the connector luer lock c45 experienced flow issues when used for infusion during use.The following information was provided by the initial reporter: material no: 515202 batch no: unknown event description: n35/c45 seemed to be clogged when starting infusion.The drug from secondary chemo bag was not pulling.Seemed like it was just pulling air.They changed n35 & c45 and everything worked fine.

• Brand Name: CONNECTOR LUER LOCK C45
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9527883
• MDR Text Key: 208192008
• Report Number: 3003152976-2019-00887
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905152024
• UDI-Public: 30382905152024
• Combination Product (y/n): N
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 515202
• Device Catalogue Number: 515202
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other