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

Catalog Number	515105
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: it was reported that white particles were observed in the liquid.While the syringe involved in the event was not returned for evaluation, three photos, one video, one used protector and one unused protector were provided to our quality team for investigation.Upon review of the photos and video, a particle was observed within the syringe.The returned protectors were inspected, no damage or related defect was observed that could have contributed to this observation.A device history review was conducted for the reported protector lot, and no deviations or nonconformances related to the reported concern were identified during manufacturing.Fragmentation testing is performed during manufacturing to evaluate any particulates generated after ten activations.Testing results were reviewed for the reported lot and results were found to be acceptable.Testing was also performed on the returned samples, the product met required specification and no particles were generated during testing.Based on the photo and video evaluation, the composition of the observed particle could not be identified; therefore, its specific origin could not be determined at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• 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: 50101617
• Report Number: 3003152976-2026-00345
• Device Sequence Number: 18642942
• Product Code: ONB
• UDI-Device Identifier: 00382905151057
• UDI-Public: (01)00382905151057(11)260310(17)310228(10)2603115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• 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,Followup
• Report Date (Section B): 09/30/2026

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: 515105
• Device Lot Number: 2603115
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown