MAUDE Adverse Event Report: BECTON DICKINSON, S.A. CONNECTOR C35-O; INTRAVASCULAR ADMINISTRATION SET

Model Number	515085
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: 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.
Event or Problem Description
It was reported that connector c35-o separated from the injector.The following information was provided by the initial reporter: it was reported the connection between the injector and connector had separated while chemotherapy was infusing.Verbatim: rn traced line due to "occlusion" alarm on alaris pump for cytarabine infusion.Rn discovered that the connection between the injector and connector had separated while chemotherapy was infusing, prompting the pump to alarm.This is despite having a blue clamp in place.This has happened multiple times this admission for this patient which is concerning.Discussed use with rn which seems appropriate-no nursing issues identified.
Event or Problem Description
It was reported that connector c35-o separated from the injector.The following information was provided by the initial reporter: it was reported the connection between the injector and connector had separated while chemotherapy was infusing.Verbatim: rn traced line due to "occlusion" alarm on alaris pump for cytarabine infusion.Rn discovered that the connection between the injector and connector had separated while chemotherapy was infusing, prompting the pump to alarm.This is despite having a blue clamp in place.This has happened multiple times this admission for this patient which is concerning.Discussed use with rn which seems appropriate-no nursing issues identified.
Additional Manufacturer Narrative
The following information has been updated due to corrected information: h6: imdrf annex g grid: g04034 connector/coupler.The following information has been updated due to additional information: d10: concomitant med prod data: m25-o infusion clamp.Injector n35-o.

• Brand Name: CONNECTOR C35-O
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12422462
• Report Number: 3003152976-2021-00552
• Device Sequence Number: 19727494
• Product Code: ONB
• UDI-Device Identifier: 00382905150852
• UDI-Public: 00382905150852
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: Other
• Device Model Number: 515085
• Device Catalogue Number: 515070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INJECTOR N35-O; M25-O INFUSION CLAMP