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	Contamination (1120); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We have experienced flakes of plastic coming off the phaseal luer lock connector (c35) twice already.The second time was with lot 2305211.These pieces of plastic get into our infusion bags during cytostatic preparation which can be very dangerous for the patient.Now we have solved this problem by "fishing out" the piece of plastic and collecting it in a syringe.In attachment you can find the pictures.
Additional Manufacturer Narrative
(b)(6): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f26 ¿ no health consequences or impact.Device problem code: a180104 - device contamination with chemical or other material.
Event or Problem Description
No additional information we have experienced flakes of plastic coming off the phaseal luer lock connector (c35) twice already.The second time was with lot 2305211.These pieces of plastic get into our infusion bags during cytostatic preparation which can be very dangerous for the patient.Now we have solved this problem by "fishing out" the piece of plastic and collecting it in a syringe.In attachment you can find the pictures.
Additional Manufacturer Narrative
Pr (b)(4) - follow up mdr for correction.D4: there were two events with one known lot number and one unknown lot number.The initial mdr was submitted with the lot information as only "unknown".The known lot number has been added.
Event or Problem Description
We have experienced flakes of plastic coming off the phaseal luer lock connector (c35) twice already.The second time was with lot 2305211.These pieces of plastic get into our infusion bags during cytostatic preparation which can be very dangerous for the patient.Now we have solved this problem by "fishing out" the piece of plastic and collecting it in a syringe.In attachment you can find the pictures.Per customer response: i myself was only present at the second incident.At the first incident, my colleagues did not quite know where the piece of plastic came from and had a suspicion that it was from the iv bag.Nothing of material was kept at that time, other than the lot number of the iv bag.Because the second incident had occurred with a different infusion bag lot number, we examined all the material and eventually found that the piece of plastic had come off the connector piece.
Additional Manufacturer Narrative
R 9219466 follow up mdr for device evaluation: both photos and the physical sample were provided to our quality team for investigation.Through visual inspection, plastic particles were observed on the connector luer and within the syringe.After proper decontamination, characterization testing was performed on the particle removed from the syringe and found it was consistent with the plastic flashes from the luer of the connector.A device history review was performed for the reported lot 2305211, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.Product undergoes visual and functional evaluations according to procedure, no issues during manufacturing related to this issue were identified during production of lot 2305011.As the first lot involved was unknown, a device history review could not be performed.While we could not identify a specific cause, it is possible it occurred during the molding process.The appropriate personnel have been notified of this incident.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.

• 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
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18154978
• Report Number: 3003152976-2023-00503
• Device Sequence Number: 6588548
• Product Code: ONB
• UDI-Device Identifier: 00382905152009
• UDI-Public: (01)00382905152009
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K123213
• 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,Followup,Followup
• Report Date (Section B): 01/31/2024

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: 515200
• Device Lot Number: 2305211
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 11/09/2023; 01/31/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 11/17/2023; 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown