MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	UNKNOWN PHASEAL
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal had a disconnection.The following information was provided by the initial reporter: material #: unknown batch#: unknown.Pharmacist noted leaking around the phaseal and the spin collar on several occasions, did not save product.Ovc rep went on sight on (b)(6)2026 and noted education was needed in locking the phaseal but also noted that the spin collar on the set was "slipping" and causing it to become loose.No patient involvement additional information provided: 1.Please provide the batch# or lot# number for the reported phaseal product? 2.Please provide the material# or ref# number for the reported phaseal product? 3.Kindly confirm whether you have observed any issues with the tubing product, given that material #10942011-04 (as lvp 20d) has been referenced in the pir complaint report.If an issue has been identified, please provide a detailed issue description along with the applicable lot number i do not have this information.It was a general observation and we were trying to figure out why it may be happening.Education was provided by bd representative and we will continue to monitor.I will make sure to record this information in the future if we continue to have issues.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Additional information: d.4.Udi investigation summary: root cause couldn't be determined due to unavailability of sample information.A complaint history review cannot be performed as no material and batch/lot number was provided.A dhr review cannot be performed as no material and batch/lot number was provided.A review of the applicable risk document indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.

• Brand Name: BD PHASEAL OPTIMA
• 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 ; 8473935694
• MDR Report Key: 24925901
• Report Number: 3003152976-2026-00185
• Device Sequence Number: 10671018
• Product Code: ONB
• UDI-Device Identifier: 10885403199363
• UDI-Public: (01)10885403199363
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: UNKNOWN PHASEAL
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 04/21/2026
• 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