MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION ADAPTER C100; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515306
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal¿ infusion adapter c100 had flow issues with air entering the infusion set through the vent line.The following information was provided by the initial reporter: "when they are using the adapter with a codan infussionset it´s coming air in to the infussionset.1.09.2023 update : it was a vent line.It was a plastic container.I have informed the customer that it should be closed then they are using a vented line.".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: one photo was provided to our quality team for investigation.Through visual inspection, there is evidence that liquid passed through the adapter as droplets are observed within the tubing.There was no visible damage or other defect that was identified within the photo that could indicate any issue with the product.A device history review was performed for reported lot 2205224, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.Retained samples of the same lot were used for additional evaluation, liquid was able to move from the syringe, through the injector and infusion adapter without issue, no issues with the device were observed.Product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, including flow rate verification.No issues were found during these inspections related to restricted flow.Based on the available information and our quality team's investigation, we are not able to identify a root cause at this time.Complaints received for this device and reported will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
It was reported that the bd phaseal¿ infusion adapter c100 had flow issues with air entering the infusion set through the vent line.The following information was provided by the initial reporter: "when they are using the adapter with a codan infussionset it´s coming air in to the infussionset.1.09.2023 update : it was a vent line.It was a plastic container.I have informed the customer that it should be closed then they are using a vented line.".

• Brand Name: BD PHASEAL¿ INFUSION ADAPTER C100
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17725958
• Report Number: 3003152976-2023-00381
• Device Sequence Number: 20620129
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: 00382905153068
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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: 04/30/2026
• Device Catalogue Number: 515306
• Device Lot Number: 2205224
• 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: 08/25/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown