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	01/14/2025
Type of Reportable Event	Malfunction
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.They would like to know if you have received similar issue with this product attachment and if you have any recommendations that would be much appreciated.Additional information was the reported event associated with a single patient or multiple patients? if it involved multiple patients, kindly specify the date of occurrence.Multiple patients date of occurrence (b)(6) 2025.In previous response received as kindly provide lot no.Not available.Product was used by 3rd party.Could you kindly verify if they are qualified healthcare professionals? yes they are qualified hospital staff.Based on above response received a follow done on below questions: requesting the response for additional details mentioned below.Could you please confirm the number of patients who have been impacted? could you please confirm if all the patients are affected by the same material and lot number? if not, could you provide the details of the other materials and lot numbers.29-jan-2025.Received an email response from complainant for information for the task#(b)(4).Answers added in additional follow up tab.(b)(6).
Additional Manufacturer Narrative
As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.If you encounter any further issues, please take a photo or keep the defective product, as this will help us identify the root causes.Based on the limited investigation results, a root cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.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: 21293162
• Report Number: 3003152976-2025-00037
• Device Sequence Number: 18038865
• 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
• Report Date (Section B): 01/30/2025

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: 01/28/2025
• Initial Report FDA Received Date: 02/03/2025
• 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