MAUDE Adverse Event Report: BECTON DICKINSON INJECTOR LUER LOCK N35C; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515004
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
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
Injector was disconnected från the hose and cytostatics have leak.Had happens couple of times before.During use additional information was patient or user harmed? if yes, please explain: no please provide the batch# information for another reported incident (had happens couple of times before.).Just info from nurses.No samples saved please provide the date of event of another reported incident (had happens couple of times before.) is this occurred single patient or different patient: no dates available please clarify exactly where leak occurred? see sfdc complain please verify did you used the infusion clamp to secure the connection of the injector and connector.Unknown was there any breakage/damage in the injector/connector? unknown please confirm, was the injector engaged with a mating connector when the pressure was applied to the syringe? unknown, have you ensured, the injector was connected properly? were there any connection issues? (loose or tight) unknown both injector and connector were disconnected from tubing? or injector disconnector from connector? unknown kindly provide the connector material# and batch#.Please see sfdc was there any infection observed following the medication? no how was the treatment successfully finalized for the customer? well please provide picture / video sample if available.Not available.
Additional Manufacturer Narrative
Pr (b)(6) follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 2405001; no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported event.Product undergoes a series of visual and functional evaluations throughout the manufacturing process, including verification that all critical dimensions are within specification such as luer threading.Testing results were reviewed for the reported lot and results were found to be acceptable.Retained samples of lot 2405001 were used for additional evaluation.All product was visually inspected, no defects were observed, and luer threading was verified to meet required specification.Based on the available information, we are not able to identify a root cause related to our manufacturing process at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: INJECTOR LUER LOCK N35C
• 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: 21934184
• Report Number: 3003152976-2025-00164
• Device Sequence Number: 5192492
• Product Code: ONB
• UDI-Device Identifier: 00382905150043
• UDI-Public: (01)00382905150043(11)240509(17)261031(10)2405001
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140591
• 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): 06/09/2025

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: 515004
• Device Lot Number: 2405001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown