MAUDE Adverse Event Report: BECTON DICKINSON BD PHASEAL PROTECTOR P50 5; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515105
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Three of our p-50 protectors leak into the expansion chambers whilst drawing out chemotherapy.¿ the issue occurred during the initial use of one of the vials, and after multiple uses on two others.¿ we used the assembly fixture to place the protector ¿ we have aspirated the amount of air equal to the volume needed in the syringe prior to attaching the injector to the syringe.No patient harm.
Additional Manufacturer Narrative
Photos received for investigation.Through visual inspection, a leak was observed inside the protection chamber, through the protective filter.Physical samples is required to further analyze and identify the root cause.A device history review was performed for reported lot 2302109, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples of lot 2302109 were used for additional evaluation.Product was visually inspected and no issues were identified.Functional testing was performed, connecting the protector samples to a vial, injector, and syringe per the instructions for use provided with the product.In all cases the expansion chamber expanded properly, liquid was able to be drawn from the vial, and the product functioned as intended with no leakage into the expansion chamber.Product undergoes a series of testing during manufacturing to ensure the quality and functionality of the device.These tests include visual inspections along with leakage testing and flow rate, all records were reviewed for the reported lot and results were found to be acceptable.Based on our investigation we are not able to identify a root cause related to our manufacturing process at this time.It is important to follow the instructions for use when using phaseal devices to ensure the product functions properly.The dose of air introduced into the vial should be equivalent to the dose of drug aspirated.
Event or Problem Description
No additional information received.

• Brand Name: BD PHASEAL PROTECTOR P50 5
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18633783
• Report Number: 3003152976-2024-00056
• Device Sequence Number: 7889603
• Product Code: ONB
• UDI-Device Identifier: 00382905151057
• UDI-Public: (01)00382905151057
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: Lay User/Patient
• Device Catalogue Number: 515105
• Device Lot Number: 2302109
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown