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 Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
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
So far, we have already experienced three times that flakes of plastic come loose from the phaseal luer lock connector (c35).The first two times there was 2305211 with lot and we had received a complaint report in february 2024.Yesterday the same problem happened for the third time, this time with lot 2405204.But because this specific product in this preparation needs to be administered through a 0,2 filter, the product could be used safely regardless the piece.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: one photo was provided to our quality team.Through visual inspection, an iv bag with white particles can be observed.No photo or physical sample of the connector was available, therefore, based on the photo, the specific composition of the particles cannot be identified.A device history review was performed for the reported lot 2405204, 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 including verification the product is free from flashes or incomplete parts, no issues during manufacturing related to this issue were identified during production of lot 2405204.Retained samples of the reported lot were used for additional evaluation.No particles or other material was found within the luer thread.While we could not identify a specific cause, bd has investigated a similar incident and found flashes developed within the luer during the molding process.Without the physical sample to evaluate, this cannot be verified for 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.
Event or Problem Description
No additional information.

• 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 (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20221127
• Report Number: 3003152976-2024-00505
• Device Sequence Number: 7328189
• Product Code: ONB
• UDI-Device Identifier: 00382905152009
• UDI-Public: (01)00382905152009(11)240529(17)280430(10)2405204
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: 2405204
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 09/15/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown