MAUDE Adverse Event Report: BECTON DICKINSON INJECTOR N40-O; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515057
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Description: it was reported leakage verbatim: we had another leak yesterday n40-o: lot 2411307, exp 4/30/27 c35-o: lot 2409502, exp 8/31/26 no apparent harm, however the patient had hazardous chemotherapy (fluorouracil) leaking on them (their skin, clothes, etc) and vapors in air no¿there was chemo all over the tubing, cassette, connectors, etc., so it was discarded as hazardous waste by the rn.
Additional Manufacturer Narrative
H11 -a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A thorough examination of the device's history was conducted for the optima connector c35-o lot 2409502 and the optima injector n40-o lot 2411307, which showed no deviations or non-conformities during the manufacturing process that could have contributed to the issue.Three retained samples of each lot were used for additional evaluation.The results of testing on the retained samples were satisfactory: no leaks were found, and the reported defect could not be replicated.Based on the current information, we are unable to identify a root cause related to the manufacturing process.Our quality team will continue to monitor complaints associated with this device and the reported condition for any potential emerging trends.
Event or Problem Description
No additional information.

• Brand Name: INJECTOR N40-O
• 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: 22394458
• Report Number: 3003152976-2025-00346
• Device Sequence Number: 9190896
• Product Code: ONB
• UDI-Device Identifier: 00382905150579
• UDI-Public: (01)00382905150579(11)241126(17)270430(10)2411307
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K201099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 515057
• Device Lot Number: 2411307
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown