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

Catalog Number	515057
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
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
Material # 515057, batch # unknown, 2312711.Verbatim: i was made aware late yesterday about this, and was informed this occurred a few other times in the past: please see xxx's email to me on what has occurred.Hi xxx, we have are experiencing issues with the locking phaseal.We have had 2 recent chemotherapy spills due the phaseal disconnecting from the line.I initially thought it was a one off, until a 2nd incident occurred last week and another today.Because we knew we had an issue staff has been vigilant about locking the pieces on.In the case today it appeared that the piece was locked on, but when pressure was applied it easily disconnected.I inspected it and kept getting the same result.We also had one incident where the piece disconnected at the patient.This was a dry disconnect so no spill.Has something changed with the device? all incidents have occurred over the past month.Are any other sites experiencing the same issue? thanks, additional information received on 27dec.For incident "where the piece disconnected at the patient" (no leak).1.Can you please provide an exact date of event in mm-dd-yyyy format? 11/25/2024 2.Can you please provide the lot number of the product associated with reported issue? did not collect the lot# information at that time.3.What was the impact to the patient? this incident did cause a chemotherapy spill.Was leaking when phaseal disconnected from iv line.4.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Minor distress only.For incident "occurred last week" (chemo leak) 1.Can you please provide an exact date of event in mm-dd-yyyy format? 12/11/2024.2.Can you please provide the lot number of the product associated with reported issue? lot # 2312711made: 12/1/23 exp: 5/31/26 3.What was the impact to the patient? chemo was dripping from phaseal at attachment to line.Rn noticed immediately.Rn reported a couple of drips 4.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No harm 5.What was the medication/fluid in use at the time of the event? yes.Medication had just been started.For incident "today (b)(6) 2024)" (chemo leak) 1.What was the impact to the patient? (b)(6) 2024.2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Minor delay.Rn noticed when attaching needle to administer sq.Additionally, can you please confirm the total number of occurrences? 3.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Pr (b)(4) 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 2312711, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.Product undergoes inspections throughout the manufacturing process, including testing to verify all critical dimensions are within specification such as the luer threading.Results were reviewed for the reported lot and no issues were identified.Three retained samples from lot 2312711 were used for additional evaluation.All product was inspected, no damage was observed on the product and all luer dimensions were verified to be within the required specifications.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.

• Brand Name: INJECTOR LOCKING N40-O MULTI
• 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: 21044971
• Report Number: 3003152976-2024-00681
• Device Sequence Number: 3278862
• Product Code: ONB
• UDI-Device Identifier: 00382905150579
• UDI-Public: (01)00382905150579(11)231211(17)260531(10)2312711
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K201099
• 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): 05/23/2025

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 515057
• Device Lot Number: 2312711
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown