MAUDE Adverse Event Report: BECTON DICKINSON, S.A. Phaseal; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Catalog Number	515056
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided by the initial reporter: material # unknown.Batch # unknown.It was reported by customer that "kink in line above the filter, one way valve on the drip chamber back flowed backwards down to the filter when connected via optima pieces, does not allow flow of the line as they do circle priming of the sets".Verbatim: 10015861a,20350e, plus optima piece.Kink in line above the filter.One way valve on the drip chamber back flowed backwards down to the filter when connected via optima pieces in a circle prime fashion when the valve on the drip chamber should be one way only up into the bag.Multiple overall complaints of kinking from this facility.Does not allow flow of the line as they do circle priming of the sets.They are having to discard the set in most cases and grab new that are not kinked.No patient impact.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: 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: 50429194
• Report Number: 3003152976-2026-00380
• Device Sequence Number: 18746388
• Product Code: ONB
• UDI-Device Identifier: 00382905150562
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: 515056
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown