MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INJECTOR (N40-O) INTRAVASCULAR ADMINISTRATION SET

Model Number 515056

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/14/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.

Event Description

It was reported when using the bd phaseal¿ optima injector (n40-o) there was a loose or separation of the injector and mating component. The following information was provided by the initial reporter. The customer stated: "the patient was found covered in blood. Chunky chemo connector found to be loose connection to iv tubing with blood spilling out of central line. " additional customer response: "after further investigation, all of the items were still attached, but the tubing was loose where it attaches to the injector. I circled the location of the leak in the photo below. The blue infusion clamp was secured over the area, but i opened it in the picture for visualization of where the leak was occurring. Due to the loose connection, blood was then back flowing from the patient and leaking. ".

• Brand Name: BD PHASEAL¿ OPTIMA INJECTOR (N40-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: 13006127
• MDR Text Key: 285473169
• Report Number: 3003152976-2021-00824
• 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: 12/29/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 515056
• Device Catalogue Number: 515056
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2021
• 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