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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported broken spike.Event description: picture of broken spike during cyto preparation.When did the incident occur? before use.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: two photos were provided to our quality team for investigation.Upon visual inspection, the c100 adapter housing is observed to be fractured, noting the spike remains connected to the iv bag.No visible damage or indicators were observed that would explain the cause of the fracture.It was reported that bags are folded in half during transport which can put excessive pressure on the device.A device history review was performed for lot 2501214, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this observation.Product undergoes visual and functional inspections throughout various stages of production, in accordance with established procedures.No issues were identified during these inspections based on the available information we are not able to determine a manufacturing related root cause at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
It is reported broken spike.Event description: picture of broken spike during cyto preparation when did the incident occur? before use the fracture was from shortly after the preparation with the sending of the iv to the service.We 'clap' the infusion in half to be able to send, which presumably puts extra pressure on the device.See photo.Both ruptures may have happened by chance with a carboplatin infusion, given that they are also the largest and most infusions that we send out this way.

• 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 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22936591
• Report Number: 3003152976-2025-00482
• Device Sequence Number: 21277971
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: (01)00382905153068(11)250114(17)281231(10)2501214
• 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
• Report Date (Section B): 01/25/2026

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: 2501214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 01/25/2026
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown