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

Catalog Number	515057
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
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
Materials#: unknown batch#: unknown verbatim: rcc received a complaint via email.Email(s) attached.We just had a connector break.The collar at the tip of the connector cracked.Pictures attached.Let us know if we need to do anything else.Additional information: 1.Are you able to provide material number and batch / lot number reported? lot# 2204302 2.How was the patient outcome? are there any clinical signs, health consequences or impact? no issues with the patient.3.Any adverse event or serious injury reported to patient or health care professional? the nurse did get docetaxel on her hands, however no long term effects have been reported.4.Are you able to provide the dates of the events in the format of mm-dd-yyyy? if unknown, can state unknown.05-16-2024 also, the cstd is still connected to a bag of docetaxel.We do not feel comfortable shipping a bag of docetaxel out.Due to the breakage of the connector, there is hazardous chemo on the connector and the bag.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: multiple photos along with the physical sample were provided to our quality team for investigation.Through visual inspection, a crack within the injector is observed.Further evaluation identified grip 2 was cracked.A device history review was performed for lot 2204302 , no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples of the reported lot were used for additional evaluation.The products were inspected and no damage within the grips was identified.Product undergoes a series of visual and functional inspections throughout the manufacturing process to ensure the quality and functionality of the device.Testing results were reviewed for the reported lot and results were found to be acceptable, no issues related to this incident were identified.While we cannot identify a direct issue, it was determined the crack observed occurred during the assembly process.Manufacturing personnel have been notified of this incident.Improvements have been implemented within the assembly machine to prevent reoccurrence of this incident, the reported lot was manufactured before these improvements were implemented.Complaints for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: INJECTOR LOCKING 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: 19370684
• Report Number: 3003152976-2024-00297
• Device Sequence Number: 12639963
• Product Code: ONB
• UDI-Device Identifier: 00382905150579
• UDI-Public: (01)00382905150579
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 10/16/2024

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: 09/30/2024
• Device Catalogue Number: 515057
• Device Lot Number: 2204302
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown