MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA PROTECTOR (P21); INTRAVASCULAR ADMINISTRATION SET

Model Number	515102
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal¿ optima protector (p21) cored out particles into the reconstituted trastuzumab solution.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter, translated from dutch: "recently there have been 2 reports in a short time that after storing the reconstituted trastuzumab sealed with a phaseal there are small white particles in the solution.These particles appear to be from the phaseal, as the particles are not present immediately after reconstitution, and were not observed until the next preparation (the next day).We stored the reconstituted trastuzumab with a particle in a syringe.".
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
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 07jun2023.H6: investigation summary: sample and photos received by our quality team for investigation.Upon visual evaluation, white particles inside the vial are observed, the vial cap appears damaged.The protector was visually inspected, no defects or issues observed.Fragmentation testing is performed according to procedure, to evaluate any particulates generated by the protector when mated to other components after ten activations.Results are within specification.A device history review was performed for reported lot 2211103, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.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.Based on the available information we are not able to identify a definitive root cause at this time.Complaints received for this device and reported issue will continue to be tracked and trended for future occurrence.
Event or Problem Description
It was reported that the bd phaseal¿ optima protector (p21) cored out particles into the reconstituted trastuzumab solution.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter, translated from dutch: "recently there have been 2 reports in a short time that after storing the reconstituted trastuzumab sealed with a phaseal there are small white particles in the solution.These particles appear to be from the phaseal, as the particles are not present immediately after reconstitution, and were not observed until the next preparation (the next day).We stored the reconstituted trastuzumab with a particle in a syringe.".

• Brand Name: BD PHASEAL¿ OPTIMA PROTECTOR (P21)
• 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: 17050223
• Report Number: 3003152976-2023-00212
• Device Sequence Number: 12510987
• Product Code: ONB
• UDI-Device Identifier: 00382905151026
• UDI-Public: 00382905151026
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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: 515102
• Device Catalogue Number: 515102
• Device Lot Number: 2211103
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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