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

Catalog Number 515070

Device Problem Disconnection (1171)

Patient Problem Chemical Exposure (2570)

Event Date 09/02/2021

Event Type  malfunction  

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 Description

It was reported that connector c35-o separation from the luer mating component. The following information was provided by the initial reporter: connector unluered off cadd pump while patient was sleeping. Email response: can you please provide additional details in regards to the issue? i do not have any more information at this time. Can you please provide the lot number? i was not provided the lot #. Can you please provide the material number? i was not provided the material #. Can you please provide the date of event? (b)(6) 2021. Would you happen to have photos you can share? i do not have any photos would you happen to have samples to return? if so, we will send a fedex pre-paid label to return samples. Please provide a direct address and phone. I was not given the connector. Was there an exposure to blood or medicines? the patient was exposed to chemo if exposure to blood or medicines what was the route of exposure? who was exposed, the healthcare provider or the patient? the patient was exposed at night while they were sleeping.

• Brand Name: CONNECTOR C35-O
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12600067
• MDR Text Key: 278604460
• Report Number: 3003152976-2021-00674
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial