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

Catalog Number	515079
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 515079 batch#: 2311501 it was reported by the customer that around 1510 when i was about to start the treatment, i saw a drop of chemo coming from the phaseal on c100.I immediately brought it to pharmacy to change medication.Verbatim: rcc received a complaint via email.Email(s) attached we had a safety event reported for bd item #s 515079 (phaseal optima infusion adapter).Let¿s identify this as bd 270, as a reference number.The defective products is available for pick up from defect depot.Please contact hector leal regarding product pickup from defect depot.Based on the information provided below, could you start a product quality report? bd 270: reported date: 4/17/2024; event date: (b)(6) 2024; item numbers: 515079; lot number: 2311501; item available for pick up?: yes; picture: no; patient harm: none; area: atc blue (acb): mays (ambulatory care bldg.).Event details: ¿around 1510 when i was about to start the treatment, i saw a drop of chemo coming from the phaseal on c100.I immediately brought it to pharmacy to change medication.¿.
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.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: several unused samples were provided to our quality team for investigation.Through visual inspection, no damage or defects were observed on any of the devices that could have contributed to the reported leak.Functional testing was performed, the adapters were properly inserted into the infusion bag, liquid was passed through the infusion adapters, in all instances the product functioned properly and no leakage was observed.A device history review was performed for reported lot 2311501, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported incident.Product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device.Testing results were reviewed for the reported lot and no issues were identified, product was verified to meet required specification.Based on the our quality team's investigation and given none of the returned samples displayed any issues related to the reported incident, we are not able to identify a root cause at this time.Complaints receive for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: INFUSION ADAPTER C100-O
• 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: 19247862
• Report Number: 3003152976-2024-00267
• Device Sequence Number: 15100702
• Product Code: ONB
• UDI-Device Identifier: 00382905150791
• UDI-Public: (01)00382905150791
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 515079
• Device Lot Number: 2311501
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown