MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION ADAPTER C100; INTRAVASCULAR ADMINISTRATION SET

Model Number	515306
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
Event or Problem Description
It was reported that the bd phaseal¿ infusion adapter c100 experienced foreign matter in fluid path.The following information was provided by the initial reporter: enduser use bd phaseal for oncology drug compounding.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
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 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¿ infusion adapter c100 experienced foreign matter in fluid path.The following information was provided by the initial reporter: enduser use bd phaseal for oncology drug compounding.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.

• Brand Name: BD PHASEAL¿ INFUSION ADAPTER C100
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16530940
• Report Number: 3003152976-2023-00059
• Device Sequence Number: 12254284
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: (01)00382905153068
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: 03/31/2026
• Device Model Number: 515306
• Device Catalogue Number: 515306
• Device Lot Number: 2204227
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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