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

Model Number	515200
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at least one bd phaseal¿ connectors luer lock (c35) leaked between the injector and connector.The following information was provided by the initial reporter: the nurse detached the chemo, turned around and disposed the bag and the patient caught our attention a minute later because blood was running back out of the female phaseal attachment from her line.It seems to only be happening with long-term hookups, so our 24 hour chemotherapy¿s.When nurses change out the bags the female port starts to leak after disconnection sometimes, almost like when the male end is removed the hub on the line remains engaged instead of closing.Again, this has only been observed with 24 hour chemo¿s.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 2010216, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, no issues related to the reported incident were found for the repotted lot.Five retained samples of the same lot were used for additional evaluation.All product was visually inspected and no defects were observed.Product could be properly connected to mating components and product was verified to meet required 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 h10.
Event or Problem Description
It was reported that at least one bd phaseal¿ connectors luer lock (c35) leaked between the injector and connector.The following information was provided by the initial reporter: the nurse detached the chemo, turned around and disposed the bag and the patient caught our attention a minute later because blood was running back out of the female phaseal attachment from her line.It seems to only be happening with long-term hookups, so our 24 hour chemotherapy¿s.When nurses change out the bags the female port starts to leak after disconnection sometimes, almost like when the male end is removed the hub on the line remains engaged instead of closing.Again, this has only been observed with 24 hour chemo¿s.

• Brand Name: BD PHASEAL¿ CONNECTOR LUER LOCK (C35)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15177046
• Report Number: 3002682307-2022-00204
• Device Sequence Number: 6330024
• Product Code: ONB
• UDI-Device Identifier: 30382905152000
• UDI-Public: 30382905152000
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

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: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 515200
• Device Catalogue Number: 515200
• Device Lot Number: 2010216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown