MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL CONNECTOR LUER LOCK (C35); INTRAVASCULAR ADMINISTRATION SET

Model Number	515200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd phaseal¿ connector luer lock (c35) did not allow injection.This was discovered during use.The following information was provided by the initial reporter: update after asking if the defect is clog: the problem was, that there was no access.The phaseal luer lock connector (c35) did not allow any injection, after connected to the injector.The phaseal connector and the phaseal injector was therefore taken off, and the injection was given without the projection from the phaseal devices.
Event or Problem Description
It was reported that bd phaseal¿ connector luer lock (c35) did not allow injection.This was discovered during use.The following information was provided by the initial reporter: update after asking if the defect is clog: the problem was, that there was no access.The phaseal luer lock connector (c35) did not allow any injection, after connected to the injector.The phaseal connector and the phaseal injector was therefore taken off, and the injection was given without the projection from the phaseal devices.
Additional Manufacturer Narrative
H.6 investigation summary : one sample unit was returned for evaluation by our quality engineer team.The connector received was connected to a luer lock connection from an infusion set c80 from lot 1905101 and then to an injector lot 0066022+ syringe (with green colorant).Upon visual inspection of the sample, no defects were observed on the connector.Functional testing was performed, connecting the sample to luer lock connection for an infusion set and a sample injector and syringe.Liquid was able to pass from the syringe though the injector and connector, and into the tubing set without issue.A device history review was performed for reported lot 1910112.No deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the available information we are not able to identify a root cause at this time.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: BD PHASEAL CONNECTOR LUER LOCK (C35)
• 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: 9759160
• Report Number: 3003152976-2020-00085
• Device Sequence Number: 2910144
• Product Code: ONB
• UDI-Device Identifier: 30382905152000
• UDI-Public: 30382905152000
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 09/30/2023
• Device Model Number: 515200
• Device Catalogue Number: 515200
• Device Lot Number: 1910112
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/14/2020
• 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