MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA; INJECTOR (N35-O MULTI)

Catalog Number	515053
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr, if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Event details: customer is experiencing multiple issues with phaseal optima connectors.They are not staying together on home chemo infusions even with the bd clamp.We had a chemo spill yesterday because of this.The 515053 piece is the one that is unscrewing from the tubing.Line disconnection, no patient harm or injury to report.Simply a disruption in delivery of chemo.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: no photographic evidence or physical samples were submitted for the investigation of the reported condition.A comprehensive review of the device's history was performed for the optima injector n35-o multi lot 2505306 and the optima connector c35-o lot 2504502, revealing no deviations or non-conformities during the manufacturing process that could have led to the issue.Three retained samples of n35-o were forwarded for further evaluation, after visual inspection of the retained injector samples, no damage or anomalies were found.Those samples were submitted to the metrology laboratory for measurement.Based on the metrology tests performed, no anomalies were identified in the retained samples that could cause leakage at the luer lock connection with other luer components.The luer lock thread meets the specification and all dimensional requirements.An engagement and disengagement test were carried out on the laboratory instrument to measure the force necessary for the connection to engage and disengage.The results indicated that all samples complied with the specified criteria.Tests on the c35-o could not be performed as no retained samples are available.The product is subjected to inspections at various stages of the manufacturing process to guarantee its quality and functionality.Based on the current information, we are unable to determine a root cause associated with the manufacturing process.Our quality team will persist in monitoring complaints related to this device and the reported condition for any potential emerging trends.

• Brand Name: BD PHASEAL OPTIMA
• Common Device Name: INJECTOR (N35-O MULTI)
• 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: 23694256
• Report Number: 3003152976-2025-00658
• Device Sequence Number: 9082666
• Product Code: ONB
• UDI-Device Identifier: 00382905150531
• UDI-Public: (01)00382905150531(11)250526(17)271031(10)2505306
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 01/12/2026

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: Lay User/Patient
• Device Catalogue Number: 515053
• Device Lot Number: 2505306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown