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

Catalog Number	515057
Medical Device Problem Codes	Fluid/Blood Leak (1250); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: medical device expiration date: unknown.H4: device manufacture date: unknown.H3: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd phaseal¿ optima injector n40-o the device broke and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: we recently had an incident with injector breaking when technician was adding the chemo.Unfortunately, they did not save the device for us to examine.¿ while a technician was preparing to draw up chemo from the vial, the injector broke off causing chemo to spill in the hood and splash on her gown and floor.This occurred as she was injecting air into the vial to inflate the expansion chamber on the phaseal protector.¿.
Additional 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.
Event or Problem Description
It was reported while using bd phaseal¿ optima injector n40-o the device broke and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: we recently had an incident with injector breaking when technician was adding the chemo.Unfortunately, they did not save the device for us to examine.¿ while a technician was preparing to draw up chemo from the vial, the injector broke off causing chemo to spill in the hood and splash on her gown and floor.This occurred as she was injecting air into the vial to inflate the expansion chamber on the phaseal protector.¿.

• Brand Name: BD PHASEAL¿ OPTIMA INJECTOR N40-O
• Common Device Name: 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17638812
• Report Number: 3003152976-2023-00357
• Device Sequence Number: 15437908
• Product Code: ONB
• UDI-Device Identifier: 00382905150579
• UDI-Public: (01)00382905150579
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K201099
• 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): 09/06/2023

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 Catalogue Number: 515057
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown