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

Model Number	515306
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 bd phaseal¿ infusion adapter c100 experienced flow issues.The following information was provided by the initial reporter: customer reported the registered nurse "changed the pump running the myozyme 3 times including the lines and had the patient re-cannulated multiple times, in case it was a vein collapse situation.Each change still resulted in a line occlusion error.The only way they could get the infusion to run, was with the removal of the inline filter, which is mandated by the data sheet and consumer information.A visual inspection of the bag hasn¿t revealed any ¿particles¿, but the alarming of the pump suggests that there is something causing a blockage.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 25-aug-2023.H6: investigation summary: one infusion adapter connected to a tube received by our quality team for investigation.Through visual evaluation, no damage or defects were observed.Functional testing was performed, attempting to pass liquid through the fluid channel, liquid passed.Device history review was performed for lot 2111218, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples from the same lot were evaluated, no defects or issue observed.A flow test was performed and liquid was able to successfully move through the device without issue.The c100 came connected to a tube, so it may be that the liquid flow problem is from the tube and not from our product.Product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, including flow rate verification.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
Event or Problem Description
It was reported that the bd phaseal¿ infusion adapter c100 experienced flow issues.The following information was provided by the initial reporter: customer reported the registered nurse "changed the pump running the myozyme 3 times including the lines and had the patient re-cannulated multiple times, in case it was a vein collapse situation.Each change still resulted in a line occlusion error.The only way they could get the infusion to run, was with the removal of the inline filter, which is mandated by the data sheet and consumer information.A visual inspection of the bag hasn¿t revealed any ¿particles¿, but the alarming of the pump suggests that there is something causing a blockage.

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17159411
• Report Number: 3003152976-2023-00238
• Device Sequence Number: 17930664
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: (01)00382905153068
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2023

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: 10/31/2025
• Device Model Number: 515306
• Device Catalogue Number: 515306
• Device Lot Number: 2111218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 08/27/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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