MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INFUSION CONNECTOR C35-O; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515070

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Initial reporter state: address information was not able to be obtained, therefore, (b)(6) was used based on facility name.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd phaseal¿ optima infusion connector c35-o a separation from the cadd tubing led to leakage.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that optima c-35 connector disconnecting from cadd tubing resulting in chemo spill.

Manufacturer Narrative

H6: 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.H3 other text : see h10.

Event Description

It was reported while using bd phaseal¿ optima infusion connector c35-o a separation from the cadd tubing led to leakage.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that optima c-35 connector disconnecting from cadd tubing resulting in chemo spill.

• Brand Name: BD PHASEAL¿ OPTIMA INFUSION 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13875350
• MDR Text Key: 288212465
• Report Number: 3003152976-2022-00117
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201099
• 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,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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
• Date Manufacturer Received: 04/12/2022
• 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
• Patient Sequence Number: 1