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

Catalog Number	515078
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd infusion adapter c100-o had a loose connection.The following information was provided by the initial reporter: the customer uses a b.Braun 1000ml saline bag for etoposide doses (occur weekly-biweekly).Bd's optima infusion adapter c100-o does not seat securely into the port of this specific 1000ml saline bag currently in use.The collar of the spike does not fit into the port, causing it to be easily pulled out.This created some concern from the pharmacists.No impact to patient.Please provide investigation response to me at (b)(6).
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: multiple photos and one b.Braun iv bag were provided to our quality team for evaluation.Upon visual evaluation of the photos, the c100-o infusion adapter was observed assembled with the iv bag.The adapter appeared to be fully inserted, and no concerns with the connection were identified.Functional testing was performed using the returned iv bag by inserting a c100-o infusion adapter into the port.The evaluation confirmed that the product connected properly, the connection was secure, and no leakage was observed during testing.The product undergoes routine inspections throughout the manufacturing process to help ensure quality and proper functionality, including verification that all dimensional requirements are met.Because the specific lot involved in this event is unknown, a device history review could not be performed, and retained samples were not available for additional evaluation.Based on the photo review and functional testing conducted with the returned iv bag, we were unable to identify a root cause related to the product or manufacturing process 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 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: 24264493
• Report Number: 3003152976-2026-00046
• Device Sequence Number: 10723139
• Product Code: ONB
• UDI-Device Identifier: 00382905150784
• UDI-Public: (01)00382905150784
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 515078
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/18/2026
• 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