MAUDE Adverse Event Report: BECTON DICKINSON, S.A. L CONNECTOR C90J

Catalog Number 515309

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.Device manufacture date: unknown.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 flow issues occurred during use with a l connector c90j.The following information was provided by the initial reporter, "injected c90j to the infusion bag and drew endoxan with n35j.When returning the drug to the infusion bag, hcp couldn't flow back.".

Event Description

It was reported that flow issues occurred during use with a l connector c90j.The following information was provided by the initial reporter, "injected c90j to the infusion bag and drew endoxan with n35j.When returning the drug to the infusion bag, hcp couldn't flow back.".

Manufacturer Narrative

H.6.Investigation: one sample l connector and one sample injector were provided to our quality team for investigation.The samples were visually inspected, no issues or other defects were identified on the spike or membrane of the connector.Liquid from the infusion bag was able to flow throughout the n35j injector and c90j l connector with no flow issues observed.Product undergoes visual and functional testing according to procedure to ensure the quality and functionality of the device.As a lot number was unavailable for this incident, a device history record review could not be completed and additional retained samples could not be investigated.Based on the available information, we are not able to identify a root cause at this time.

• Brand Name: L CONNECTOR C90J
• Type of Device: CONNECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9554821
• MDR Text Key: 179522225
• Report Number: 3003152976-2019-00908
• Device Sequence Number: 1
• Product Code: FMG
• 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: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515309
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other