MAUDE Adverse Event Report: BECTON DICKINSON, S.A. CONNECTOR LUER LOCK C45J

Catalog Number 515206

Device Problem Infusion or Flow Problem (2964)

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

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

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 flows issues occurred before use with a connector luer lock c45j.The following information was provided by the initial reporter, "drug didn't flow.After replaced by new product, the issue was resolved.".

Manufacturer Narrative

H.6.Investigation: one sample was returned to our quality team for investigation.Upon visually inspecting the product, no defects were identified.A flow test was performed using the sample c45 connector with a syringe and n35 injector, no occlusions or flow issues were observed.A device history record review found no non-conformances associated with this issue during production of batch 1810107.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.Testing was reviewed for the reported lot and all results were found to be within specification.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.H3 other text : see h.10.

Event Description

It was reported that flows issues occurred before use with a connector luer lock c45j.The following information was provided by the initial reporter, "drug didn't flow.After replaced by new product, the issue was resolved.".

• Brand Name: CONNECTOR LUER LOCK C45J
• Type of Device: CONNECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8996406
• MDR Text Key: 160223914
• Report Number: 3003152976-2019-00620
• Device Sequence Number: 1
• Product Code: LHI
• 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: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 515206
• Device Lot Number: 1810107
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other