MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR (P55); INTRAVASCULAR ADMINISTRATION SET

Model Number	515117
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	11/12/2022
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 2 bd phaseal¿ protectors (p55) experienced foreign matter within the fluid path.The following information was provided by the initial reporter: this is a report about coring.When the protector (p55) was attached to the vial of endoxan using assembly fixture, rubber piece-like fm was found.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 18-jan-2023.H6: investigation summary: one protector attached to a vial was returned to our quality team for investigation.The product was visually inspected, the protector fit securely to the vial, no damage was observed on the protector membrane, however the spike was observed to be bent at the tip.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 lot 2112123, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.Fragmentation testing is performed according to procedure, to evaluate any particulates generated by the injector when mated to other components after ten activations.Results were reviewed for the reported lot and verified to be within required specification.Retained samples of the same lot were used for additional evaluation.The protectors were connected to a vial, using a sample injector, the membrane was penetrated up to ten times.In all cases the product functioned as intended and no coring or particle generation was observed.While phaseal needles are designed to reduce coring, there are several factors that may impact coring tendency.Coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.It is important to ensure the vial is not expired as that can impact the quality of the rubber stopper.It is important to ensure the protector is used with the proper vial given the spike is not metal.The m12 assembly fixture is recommended to ease connection of the protector onto the vial.Based on the available information we are not able to identify a definitive root cause at this time.
Event or Problem Description
It was reported that 2 bd phaseal¿ protectors (p55) experienced foreign matter within the fluid path.The following information was provided by the initial reporter: this is a report about coring.When the protector (p55) was attached to the vial of endoxan using assembly fixture, rubber piece-like fm was found.

• Brand Name: BD PHASEAL¿ PROTECTOR (P55)
• 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: 15928511
• Report Number: 3003152976-2022-00543
• Device Sequence Number: 6544613
• Product Code: ONB
• UDI-Device Identifier: 50382905151175
• UDI-Public: 30382905151171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/14/2023

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: 515117
• Device Catalogue Number: 515117
• Device Lot Number: 2112123
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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