MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD Phaseal; Closed antineoplastic and hazardous drug reconstitution and transfer system

Catalog Number	515629
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided by the initial reporter: according to the customer report, an incident occurred where air entered in the iv line during chemotherapy use.The product was recalled.Since air was detected in the iv line during administration, the iv connection line was exchanged.(small container) air entered the iv line again during administration using the new iv connection line.Although we reported the possibility that air had entered from the jms spike with an air vent, we were asked to investigate, so we recalled the product.Contaminated with it is the route through which the anticancer drug is administered.Additional information received on 07 sep 2026.Thank you for contacting us.Did this occur in the primary line or the secondary line? it occurred in the primary line.Did this occur while an infusion pump was in use? it likely occurred while the pump was in use.Is the iv administration set manufactured by bd? it is manufactured by jms.Was the iv administration set vented? unknown.If it was vented, was the vent inlet closed? was the iv administration set primed before the infusion started? yes, it was primed.How much time had passed since the infusion started when this occurred? approximately 10 minutes later.Was air observed only within the iv line? only in the iv line.Were any loose connections observed? none in particular.If so, where? the jms infusion line is included in the returned items.Since the jms infusion line is equipped with an air vent, we suspect that air ingress through this vent was the cause.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD Phaseal
• Common Device Name: Closed antineoplastic and hazardous drug reconstitution and transfer system
• 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 ; +1(847)393-5694
• MDR Report Key: 50828908
• Report Number: 3003152976-2026-00435
• Device Sequence Number: 10575776
• Product Code: ONB
• UDI-Device Identifier: 00382905156298
• UDI-Public: (01)00382905156298(11)260330(17)280229(10)2603509
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K250059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 515629
• Device Lot Number: 2603509
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown