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

Model Number 515056

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2022

Event Type  malfunction  

Event Description

It was reported that the bd phaseal¿ optima injector (n40-o) luer connection separated from the connector, causing fluid to leak out. This occurred 3 separate times during use. The following information was provided by the initial reporter: "having issues mainly with the 5fu pumps and the n-35 & n-40 pieces. These issues have resulted in three "spills" over the last two days requiring pharmacy attention to clean up. What seems to be occurring is, although the n-35 /n-40 and connector pieces are attached and encased in the blue clamps, there is just enough wiggle room to allow for movement. What we are seeing is that the little bit of movement is creating a slight disconnect between the two pieces, as the fluid is running it is ever so slightly leaking out of the connector pieces and into the clamps. ".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

• 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: 14253033
• MDR Text Key: 290545852
• Report Number: 3003152976-2022-00181
• 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
• Report Date: 04/18/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/29/2022
• 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: 2107307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial