MAUDE Adverse Event Report: BECTON DICKINSON, S.A. CONNECTOR LUER LOCK C45; PHASEAL -CLOSED DRUG DELIVERY SYSEM

Catalog Number	515202
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the connector luer lock c45 experienced leakage during use.The following information was provided by the initial reporter: material no.: 515202, batch no.: 1811107.Per email: phaseal connector attached to the lower y-site on the primary bd tubing.Infusing through the primary line.Dripping out phaseal onto the patient.
Additional Manufacturer Narrative
Investigation: no photos or physicals samples that display the reported issue were provided for investigation.Five retained samples were evaluated, no defects were observed upon inspecting the product and no leaks were observed.The connector was attached to an infusion set and performed as expected with no leakage identified.A device history review was performed for reported lot 1811107, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product is inspected throughout the manufacturing process to ensure the quality and functionality of the device.It is important to note that the performance of the sealing membrane is reduced after multiple perforations and extended activation time, it is not recommended to have more than ten perforations.
Event or Problem Description
It was reported that the connector luer lock c45 experienced leakage during use.The following information was provided by the initial reporter: material no.: 515202 ,batch no.: 1811107.Per email: phaseal connector attached to the lower y-site on the primary bd tubing.Infusing through the primary line.Dripping out phaseal onto the patient.

• Brand Name: CONNECTOR LUER LOCK C45
• Common Device Name: PHASEAL -CLOSED DRUG DELIVERY SYSEM
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9119575
• Report Number: 3003152976-2019-00668
• Device Sequence Number: 2183876
• Product Code: ONB
• UDI-Device Identifier: 30382905152024
• UDI-Public: 30382905152024
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (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): 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 515202
• Device Lot Number: 1811107
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other