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

Catalog Number	515202
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12089635
• Report Number: 3003152976-2021-00353
• Device Sequence Number: 3848783
• Product Code: ONB
• UDI-Device Identifier: 00382905152023
• UDI-Public: 00382905152023
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 515202
• Device Lot Number: 2010702
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1