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

Catalog Number 515202

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that connector luer lock c45 had flow issues.The following information was provided by the initial reporter: it was reported that luer lock connector had to be changed before pumps would allow the infusion to begin on two occasions.

Manufacturer Narrative

H.6.Investigation: one photo which displays the used connector was provided to our quality team, no physical sample was available for evaluation.Upon inspection of the photo, there was no visible damage or defects on the connector that could have contributed to the reported failure.A device history review was performed for reported lot 2010702, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the alleged defect.Three retained samples were used for additional evaluation.The product was visually inspected and no damage or defects were observed.The samples were functionally tested, connecting a sample syringe and injector to a sample protector along with the vial according to the instructions for use.The liquid was successfully aspirated from the vial, then connecting the injector to the retained sample connectors.In all cases, liquid could properly flow from the syringe through the injector and connector without issue and no resistance occurred.Product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, including flow rate verification and confirmation all critical parts are within specification, all records were reviewed for the reported lot and results were found to be acceptable.Based on the available information we are not able to determine a root cause at this time.H3 other text : see h.10.

Event Description

It was reported that connector luer lock c45 had flow issues.The following information was provided by the initial reporter: it was reported that luer lock connector had to be changed before pumps would allow the infusion to begin on two occasions.

• 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: 12089635
• MDR Text Key: 263233313
• Report Number: 3003152976-2021-00353
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00382905152023
• UDI-Public: 00382905152023
• 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: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515202
• Device Lot Number: 2010702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1