MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P50; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515105
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	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr 9339233: initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Rcc received a complaint via email.Email(s) attached.Caller states they use the phaseal p50 protector 515105 and the phaseal n35 injector 515003.Then they dilute the drug with the saline, they are noticing particulates in the solution.Caller is wanting to know if these phaseal products are prone to producing visible particulates within the solution, specifically with ps80 and saline.Customer emailed while transferring the diluent (0.9% saline and ps80) to the drug vial using the n35 injector (lot 2302007)and p50 protector(lot 2304106), followed by some repeated aspiration to ensure homogenized mixture in the vial, it is noted that at times visible particle formation can be observed.Particles are irregular in shape and white in color.The particle formation is absent when aspiration with syringe is absent or reduced.Could you please advise if any of these bdphaseal components are prone to visible particle issue to your knowledge with ps80 or saline? informed caller we would need to forward this on to our medical affairs team to reach out for further discussion.In the meantime, we will also need to submit this to our product complaints team as a potential complaint.Suggested caller email a description of the issue they are experiencing and include the product lot numbers.Forwarded customer email to joanne beyer for further discussion.Forwarded to product complaints via email.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
No photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number 515105 and lot number 2302007.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.Retained samples from the same lot were evaluated, no issues or defects observed.Fragmentation testing is performed according to procedure, to evaluate any particulates generated by the injector when mated to other components after ten activations.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, an exact cause for this incident could not be identified.

• Brand Name: PROTECTOR P50
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18363417
• Report Number: 3003152976-2023-00543
• Device Sequence Number: 20860185
• Product Code: ONB
• UDI-Device Identifier: 00382905151057
• UDI-Public: (01)00382905151057
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: Health Professional
• Device Catalogue Number: 515105
• Device Lot Number: 2304106
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown