MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P21; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515102
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	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that protector p21 had foreign matter.The following information was provided by the initial reporter: it was manually placed on a vial of kadcyla.This vial contains trastuzumab-emtansin powder.While dissolving the powder with aqua for injection, we noticed a particle of the septum in the vial.Correct volume was then withdrawn very carefully by syringe from vial, making sure that particle remained in vial.
Event or Problem Description
It was reported that protector p21 had foreign matter.The following information was provided by the initial reporter: it was manually placed on a vial of kadcyla.This vial contains trastuzumab-emtansin powder.While dissolving the powder with aqua for injection, we noticed a particle of the septum in the vial.Correct volume was then withdrawn very carefully by syringe from vial, making sure that particle remained in vial.
Additional Manufacturer Narrative
H.6.Investigation: one photo was provided to our quality team for investigation.Through visual inspection, a foreign particle was observed inside the vial.While the particles appear to be consistent with the rubber stopper of the vial, without the physical sample to evaluate, we cannot confirm the origin.A device history review was performed for lot 2011110, no deviations or non-conformances were identified during the manufacturing process that could have contributed to these issues.Fragmentation testing is performed according to procedure, to evaluate any particulates generated by the injector when mated to other components after ten activations.Testing was reviewed for lot 2011110 and results were found to be acceptable.Four retained samples of the same lot were used for additional evaluation.Fragmentation testing was performed using the retained protectors and sample injectors, in all cases the product met required specifications.Based on the available we are not able to identify a definitive root cause at this time.

• Brand Name: PROTECTOR P21
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 11918100
• Report Number: 3003152976-2021-00307
• Device Sequence Number: 11563852
• Product Code: ONB
• UDI-Device Identifier: 00382905151026
• UDI-Public: 00382905151026
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 10/31/2025
• Device Catalogue Number: 515102
• Device Lot Number: 2011110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1