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

Catalog Number	515105
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow up mdr for correction.Following the submission of the initial mdr, it was noted that an incorrect verbiage was used in section h10.Corrected verbiage: initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
No additional information.
Event or Problem Description
Clinician reported that she had three seperate incidents of the phaseal coring the rubber on the infliximab vial.She said she did not do anything different to what she normally does and has been very careful with the way she pierces the vial.She has provided photos of the rubber within the phaseal protector.She contatced pharmacy and was told it was still safe to use the medication.
Additional Manufacturer Narrative
Following the submission of the initial mdr, it was determined that the complaint was submitted in error.There was no identified defect or malfunction.This mdr will be void and the complaint cancelled.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: two photos were provided to our quality team for investigation.Through visual inspection, a piece of what appears to be the rubber stopper is observed inside the vial.Given the stopper is not visible within the photos, it cannot be fully verified.A device history review was performed for reported lot 2306114, 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 after ten activations.Fragmentation testing was reviewed for the reported lot and results were found to be acceptable.Retained samples from lot 2306114 were used for additional evaluation.Functional testing was performed, penetrating the protector with a sample injector ten times.In all cases the product functioned as intended and no coring was identified.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 the specific root cause at this time.The m12 assembly fixture is recommended to ease the connection of the protector to the vial and must be used in a steady and consistent motion.Complaints received for this device and reported condition will continue to be tracked and trended for future occurrence.

• 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: 19607654
• Report Number: 3003152976-2024-00376
• Device Sequence Number: 18163885
• Product Code: ONB
• UDI-Device Identifier: 00382905151057
• UDI-Public: (01)00382905151057
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2024

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: 2306114
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: Not provided; 11/14/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 06/25/2024; 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown