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

Catalog Number	515064
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Description: it was reported by customer that when making a mitomycin dose the drug could not be reconstituted after applying the protector.The soft rubber sheath covering the spike seemed to become stuck part way.Verbatim: material#: 515064 batch#: unknown at cen yesterday, when making a mitomycin dose the drug could not be reconstituted after applying the protector.The soft rubber sheath covering the spike seemed to become stuck part way.We didn't have another vial of drug so we removed the protector and applied a new one.The defective one was saved.We have 2 lot number and are not certain which one was used as the packaging was discarded: 2411403, 2409405.
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
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: one photo and two physical samples were provided to our quality team for investigation.Upon inspection, no damage was observed within the spike sleeve or spike of the protectors.Functional testing was completed, liquid was able to move from a syringe through the protectors without issue, and the product performed as intended.A device history review was performed for suspected lots 2409405 and 2411403, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported event.Three retained samples of each suspected lot was used for additional evaluation.The product was visually inspected and no damage or defects were observed.Functional testing was performed, in all cases the protectors were properly fitted to the vial without issue, no damage to the spike or spike sleeve occurred, and all product functioned properly.As part of our standard manufacturing process, each product undergoes visual and functional testing to ensure quality and performance.No issues related to the reported concern were observed during these inspections.Based on the sample evaluation and our quality team's investigation, we cannot identify a root cause at this time.Complaints received for this device and reported condition will 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: 22059451
• Report Number: 3003152976-2025-00226
• Device Sequence Number: 8478169
• Product Code: ONB
• UDI-Device Identifier: 00382905150647
• UDI-Public: (01)00382905150647
• 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): 07/09/2025

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 Catalogue Number: 515064
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/09/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown