MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA PROTECTOR P13-O; INTRAVASCULAR ADMINISTRATION SET

Model Number	515060
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with bd phaseal¿ optima protector p13-o the rubber stopper dislodges into vial.There was no report of patient impact.The following information was provided by the initial reporter: the optima assembly fixture was used with the p13-o to spike a vial of vectibix.This vial has a flat vial stopper.This was a veteran staff member whom is familiar with this system.The rubber stopper pushed all the way into the vial.This is the first time this has happened with this vial and our p13-o.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary photos received by our quality team for investigation.Through visual inspection of the picture, the protector is assembled in the vial, but the rubber stopper has been disassembled from the vial and has fallen into the medicine vial.Through visual evaluation of the samples, no defects or issues observed.Functional testing was performed, connecting the protector sample to both 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.A device history review was performed for lot 2111401, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Three retained samples from the lot were evaluated, no defects or issues observed.Functional testing was performed, connecting the protector sample to both 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.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 the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
Event or Problem Description
It was reported that during use with bd phaseal¿ optima protector p13-o the rubber stopper dislodges into vial.There was no report of patient impact.The following information was provided by the initial reporter: the optima assembly fixture was used with the p13-o to spike a vial of vectibix.This vial has a flat vial stopper.This was a veteran staff member whom is familiar with this system.The rubber stopper pushed all the way into the vial.This is the first time this has happened with this vial and our p13-o.

• Brand Name: BD PHASEAL¿ OPTIMA PROTECTOR P13-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.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17131479
• Report Number: 3003152976-2023-00233
• Device Sequence Number: 12362266
• Product Code: ONB
• UDI-Device Identifier: 00382905150609
• UDI-Public: (01)00382905150609
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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 Expiration Date: 10/31/2023
• Device Model Number: 515060
• Device Catalogue Number: 515060
• Device Lot Number: 2111401
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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