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

Model Number	515060
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal¿ optima protector experienced foreign matter within the vial.The following information was provided by the initial reporter: when using the p13-o protector, there was white particulate within the vial of panitumumab.No patient impact, but they have had to waste this drug and this is very expensive.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd phaseal¿ optima protector experienced foreign matter within the vial.The following information was provided by the initial reporter: when using the p13-o protector, there was white particulate within the vial of panitumumab.No patient impact, but they have had to waste this drug and this is very expensive.
Additional Manufacturer Narrative
H.6.Investigation summary: no physical samples that display the reported condition were provided for investigation.One photo was received, through visual inspection of the image, white particles were observed with the liquid in the vial, however, without the physical sample we are unable to properly identify the composition or origin of the observed particles.A device history review was performed for lot 2109401, no deviations or non-conformances were identified during the manufacturing process that could have contributed to these issues.Fragmentation testing is performed during manufacturing to evaluate any particulates generated after ten activations.Testing results were reviewed for the reported lot and results were found to be acceptable.Five retained samples of lot 2109401 were used for additional evaluation.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 liquid was able to be drawn from the vial without issue and no particles were observed within the vial.Fragmentation testing was also performed on the retained product, penetrating the protector with a sample injector ten times.All results were found to be within specification.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see h.10.

• Brand Name: BD PHASEAL¿ OPTIMA PROTECTOR
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14877219
• Report Number: 3003152976-2022-00302
• Device Sequence Number: 5666216
• Product Code: ONB
• UDI-Device Identifier: 00382905150609
• UDI-Public: 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): 08/02/2022

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: 08/31/2023
• Device Model Number: 515060
• Device Catalogue Number: 515060
• Device Lot Number: 2109401
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2021
• 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