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	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
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
Met with nerissa to further understand the pir's below: (b)(4).Capital and coast are experiencing a "foreign matter" in the iv bags, it looks small and white with a potential plastic nature.She is unsure where this is coming from, possibly phaseal? nerissa bought along some of the bags with the "foreign matter".We looked for a good 20 minutes trying to find this matter, i was able to identify one which i took photos of.Th rest i could not identify, but it is so small that its hard to see.- it's mainly with trastuzumab (grey vial bung) and rituximab (grey vial bung) but can occur with other drugs.- its happening in baxter pvc and non pivc bag.- no drawing up needle used - they have a strict inspection policy for looking for foreign matter, in all cases it has not occurred until they attach injector (515003) to the bag adapter (515306).So they check the syringe before injecting into bag and aren't seeing the matter.Please see attached photos.
Additional Manufacturer Narrative
Following the submission of the initial mdr, it was noted that the incorrect medical device brand name was reported.Medical device brand name corrected to injector luer lock n35.
Event or Problem Description
No additional information.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: multiple iv bags with the infusion adapter attached were provided to our quality team for investigation.Through visual inspection, particles were observed within the iv bag.The particles appeared white in color and based on visual characteristics, it is believed to be small particles of the phaseal membrane.Unfortunately, we were not able to safely extract the particles, therefore the specific composition cannot be identified at this time.Fragmentation testing is performed according to procedure, to evaluate any particulates generated by the injector when mated to other components after ten activations.As a lot number was unavailable for this incident, a device history record review could not be completed.While phaseal needles and spikes are designed to reduce coring, there are several factors that may impact coring tendency.Coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used.Based on the available information, we are not able to identify a root cause related to the manufacturing process at this time.Complaints received for this device and reported condition will continue to be tracked and trended for future occurrence.

• 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: 19782013
• Report Number: 3003152976-2024-00417
• Device Sequence Number: 18212386
• Product Code: ONB
• UDI-Device Identifier: 00382905150036
• UDI-Public: (01)00382905150036
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup,Followup
• Report Date (Section B): 10/03/2024

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
• 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: 07/09/2024
• Supplement Date Received by Manufacturer: Not provided; 10/03/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 07/22/2024; 10/03/2024
• 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