MAUDE Adverse Event Report: BECTON DICKINSON INFUSION ADAPTER C100; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515306
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
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
Description/event details: i want to relay feedback from one of our customers using bd phaseal infusion adapter c100.They had few incidents where significant volumes of air have come into the line despite having drug remaining in the bag (with bd phaseal infusion adapter c100 attachment) and this cause significant disruption during infusion.Additional information: when did the incident occurred (before, during or after use) during use.Date of occurrence: (b)(6)2025.Quantity involved: (b)(4).Kindly provide lot no.Not available.Product was used by 3rd party.Is the iv line is vented or non-vented? non-vented.Could you provide information for the medication/container that is being used as well? rituximab bags.
Event or Problem Description
Description/event details: i want to relay feedback from one of our customers using bd phaseal infusion adapter c100.They had few incidents where significant volumes of air have come into the line despite having drug remaining in the bag (with bd phaseal infusion adapter c100 attachment) and this cause significant disruption during infusion.Additional information: when did the incident occurred (before, during or after use) during use date of occurrence (b)(6)2025 quantity involved (b)(4) kindly provide lot no.Not available.Product was used by 3rd party.Is the iv line is vented or non-vented? non vented.Could you provide information for the medication/container that is being used as well? rituximab bags.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause at this time.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: INFUSION ADAPTER C100
• 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: 21218719
• Report Number: 3003152976-2025-00019
• Device Sequence Number: 3480281
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: (01)00382905153068
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Report Date (Section B): 01/29/2025

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: 515306
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown