MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50; INTRAVASCULAR ADMINISTRATION SET

Model Number	515105
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
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¿ protector p50 experienced foreign matter contamination.The following information was provided by the initial reporter: particles have been found in drug vial x1 and saline bag x1.Particles are suspected to be caused by coring when user insert bd protector onto the vial or when inserting infusion adaptor into the saline bottle.
Event or Problem Description
It was reported that the bd phaseal¿ protector p50 experienced foreign matter contamination.The following information was provided by the initial reporter: particles have been found in drug vial x1 and saline bag x1.Particles are suspected to be caused by coring when user insert bd protector onto the vial or when inserting infusion adaptor into the saline bottle.
Additional Manufacturer Narrative
H6: investigation summary: two photos were provided to our quality team for investigation.Through visual inspection, particles are observed inside the vial.Without the physical sample to evaluate, we cannot identify the composition or origin of the particles.A device history review was performed for protector lot 2202131, injector lot 2205001, and infusion adapter lot 2204227, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.Fragmentation testing is performed during manufacturing to evaluate any particulates generated after ten activations.Testing results were reviewed for the reported lots and results were found to be acceptable.Retained samples from the reported protector, injector, and adapter lots were used for additional evaluation.Functional testing was also performed, penetrating the protector and adapter with a sample injector ten times.In all cases the product functioned as intended and no coring was identified.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 the bd phaseal¿ protector p50 experienced foreign matter contamination.The following information was provided by the initial reporter: particles have been found in drug vial x1 and saline bag x1.Particles are suspected to be caused by coring when user insert bd protector onto the vial or when inserting infusion adaptor into the saline bottle.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 14-apr-2023.H6: investigation summary.Two photos were provided to our quality team for investigation.Through visual inspection, particles are observed inside the vial.Additionally, one protector and vial returned to our quality team for investigation.During our evaluation, a foreign particle was observed inside the vial.Characterization testing was performed and found the particle was consistent with material from the rubber stopper of the vial.A device history review was performed for protector lot 2202131, injector lot 2205001, and infusion adapter lot 2204227, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.Fragmentation testing is performed during manufacturing to evaluate any particulates generated after ten activations.Testing results were reviewed for the reported lots and results were found to be acceptable.Retained samples from the reported protector, injector, and adapter lots were used for additional evaluation.Functional testing was also performed, penetrating the protector and adapter with a sample injector ten times.In all cases the product functioned as intended and no coring was identified.H3 other text : see h10.

• Brand Name: BD PHASEAL¿ PROTECTOR P50
• 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 ; 8448235433
• MDR Report Key: 16530917
• Report Number: 3003152976-2023-00060
• Device Sequence Number: 5980293
• Product Code: ONB
• UDI-Device Identifier: 30382905151058
• UDI-Public: (01)30382905151058
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K123213
• 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,Followup
• Report Date (Section B): 05/11/2023

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 Model Number: 515105
• Device Catalogue Number: 515105
• Device Lot Number: 2202131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 03/23/2023; 05/11/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 03/31/2023; 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2022
• 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