MAUDE Adverse Event Report: BECTON DICKINSON INJECTOR LUER LOCK N35; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515003
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr with device evaluation.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging issues.
Event or Problem Description
Oncology team staff member emailed specialist to report the phaseal adapter on 1 fluorouracil syringe for patient rt was not secured properly.Customer that when the nurse twisted the adapter into the cannula, the luer lock within the syringe came loose and detached from the syringe.Customer confirmed this did not result in cytotoxic exposure to the nurse.No third party notification is required for this event as the ancillary attachment is added during the compounding of this product, if there were any quality issues with the ancillary attachment, this would have been identified during compounding and attachment rejected; compounding investigation only required.Qa specialist forwarded additional information from customer confirming no leak occurred during this event.Customer reported there was no damage observed to the product packaging, or the carton the product was received in; prior to the incident occurring.Customer also reported the patient did not miss their treatment, the product was used as the nurse re-attached the adaptor.Customer also confirmed there was no report of patient / staff injury or medical intervention as a result of this event, however stated "potential for exposure if incident was to recur".This was identified at the hospital during setup / preparation.There was no report of patient injury or medical intervention as a result of this event.The actual sample was used by the customer, no photographs have been provided for investigation.Fluorouracil.

• Brand Name: INJECTOR LUER LOCK N35
• 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: 19047126
• Report Number: 3003152976-2024-00206
• Device Sequence Number: 8482799
• Product Code: ONB
• UDI-Device Identifier: 00382905150036
• UDI-Public: (01)00382905150036
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 04/04/2024

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 Catalogue Number: 515003
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown