MAUDE Adverse Event Report: BECTON DICKINSON PHASEAL OPTIMA; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515078
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material#: 515078.Batch#: 2409504.It was reported by customer that they had a carboplatin leak at the chairside (contained) as the phaseal optima snapped off when nurse was trying to spike the bag.Phaseal optima (red arrow shows weak point, this extension is very flimsy, took very little force to snap it off).They snapped off easily both with cap on and with cap off.Verbatim: here are photos you requested.Please assess and caution nursing staff if appropriate.Context: yesterday may 8/2025 - we had a carboplatin leak at the chairside (contained) as the phaseal.Optima snapped off when nurse was trying to spike the bag.Phaseal optima (red arrow shows weak point, this extension is very flimsy, took very little force to snap it off).We snapped off easily both with cap on and with cap off.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: one photo was provided to our quality team for investigation.Through visual inspection, the connection stick of the adapter is observed broken, verifying the reported incident.There is no other visible defect that can be identified to indicate why the breakage occurred.A device history review was performed for lot 2409504, no deviations or non-conformances were identified during the manufacturing process that could have contributed to reported concern.Retained samples of the same lot were used for additional evaluation.The product was thoroughly inspected, no defects were observed within any of the samples.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including attachment and detachment testing as well as separation force.All results were reviewed for lot 2409504 and results were found to be acceptable, with no indications of issues related to the reported concern.The retained samples also underwent this testing and verified product met required specification.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: PHASEAL OPTIMA
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 22029816
• Report Number: 3003152976-2025-00214
• Device Sequence Number: 20958143
• Product Code: ONB
• UDI-Device Identifier: 00382905150784
• UDI-Public: (01)00382905150784(11)240930(17)260831(10)2409504
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181221
• 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): 09/03/2025

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 515078
• Device Lot Number: 2409504
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown