MAUDE Adverse Event Report: BECTON DICKINSON CONNECTOR LUER LOCK C35; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515200
Medical Device Problem Codes	Complete Blockage (1094); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Patient problem code: f26 ¿ no health consequences or impact.Device problem code: a140901 - complete blockage.
Event or Problem Description
Material#: 515200 batch#: 2108207.It was reported by customer that customer called in to report that the nurses are having trouble with the c35 not pushing anything out, product is clogged.Nursing staff stated they were unable to push the drug azacidine through the phaseal and luer lock connector.The nurses began removing the c35 connector and adding the needle to the phaseal which allowed them to push it through.Not using the c35 could lead to exposure.I have since reached out to nursing 2 more times and they have not responded.You may close the case.If the issue occurs in the future i will reach out to bd.
Event or Problem Description
The following information was requestion: 1.Are they completing the infusion with a new device? if yes, are they replacing the connector? injector? or both? 2.Is there any visible damage or other issue observed on the device that could be contributing to the reported incident? 3.Can they provide the injector information they are using along with the connector.Per customer response: nursing staff stated they were unable to push the drug azacidine through the phaseal and luer lock connector.The nurses began removing the c35 connector and adding the needle to the phaseal which allowed them to push it through.Not using the c35 could lead to exposure.I have since reached out to nursing 2 more times and they have not responded.You may close the case.If the issue occurs in the future i will reach out to bd.
Additional Manufacturer Narrative
Investigation summary: no samples or photos received by our quality team for investigation.A device history review was performed for the reported lot 2108207no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples from the same lot were evaluated, no defects or issues observed.Functional testing was performed, liquid could move without issue and no leaks were observed.Product undergoes a series of testing during manufacturing to ensure the quality and functionality of the device.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.

• Brand Name: CONNECTOR LUER LOCK C35
• 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18255908
• Report Number: 3003152976-2023-00520
• Device Sequence Number: 15114293
• Product Code: ONB
• UDI-Device Identifier: 00382905152009
• UDI-Public: (01)00382905152009
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• 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): 02/21/2024

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: 07/31/2025
• Device Catalogue Number: 515200
• Device Lot Number: 2108207
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown