MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL; INFUSION ADAPTER (C100)

Catalog Number	515306
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr.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
Event details: pharmacist from (b)(6) emailed baxter anz sales manager compounding on 8 jan 2026 to report 1 paclitaxel bag was supposed to run over 3 hours, however took 6 hours to run.Customer reported that nurses replaced the machine and checked there was no patient issue slowing infusion time.Due to process of elimination, customer believes either the phasal adaptor ancillary attachment added at baxter was faulty (code 515306, batch 2502214), or the administration set (no administration set provided by baxter with this product).Customer advised there have been no other issues.This was identified at the hospital during infusion from 10:20 to 16:30, on (b)(6) 2026.There was no report of patient injury or medical intervention as a result of this event.The actual sample is contaminated with cytotoxic solution and cannot be retrieved; however, a photograph has been provided for investigation.Baxter compounding services product: paclitaxel (accord) 279mg in sodium chloride 0.9% viaflo bag.
Additional Manufacturer Narrative
One photo was provided to our quality team for investigation.Through visual inspection, there is no visible damage or other defect identified within the photo that could indicate any issue with the product.A device history review was performed for reported lot 2502214, 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.
Event or Problem Description
No additional information.

• Brand Name: BD PHASEAL
• Common Device Name: INFUSION ADAPTER (C100)
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24225278
• Report Number: 3003152976-2026-00026
• Device Sequence Number: 8392360
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: (01)00382905153068(11)250224(17)290131(10)2502214
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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 Catalogue Number: 515306
• Device Lot Number: 2502214
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown