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	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 515057 batch # 2310305 it was reported by customer that the locking injector is un-luering from the tubing set and is concerned if the injector is compatible with the tubing being used.This led to patient bleeding from the huber needle and a chemo spill verbatim: the locking injector is un-luering from the tubing set.Concerned if the injector is compatible with the tubing being used.I have samples of both injectors from the lot and the tubing being used.Please advise on if they are compatible.
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.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: one n40 injector sample and three tubing sets, not manufactured by bd, were received for investigation.Through visual inspection, no damage or other defects were observed which could contribute to the reported incident.Functional testing was performed, the injector was luered onto the iv sets without issue and no disconnection occurred.Dimensional testing was performed, including the luer thread, verifying all critical dimensions are within specification.A device history review was performed for reported lot 2310305, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.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.Retained samples from lot 2310305 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.It is important to follow the instructions for use when engaging the device with a mating luer component to ensure all luer connections are securely tightened before use.Based on the sample evaluation and quality team's investigation, we are not able to identify a root cause related to our device 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.
Event or Problem Description
No additional information.

• 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 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19583029
• Report Number: 3003152976-2024-00363
• Device Sequence Number: 3505918
• Product Code: ONB
• UDI-Device Identifier: 00382905150579
• UDI-Public: (01)00382905150579
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2024

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: 03/31/2026
• Device Catalogue Number: 515057
• Device Lot Number: 2310305
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown