MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL; PROTECTOR (P21)

Catalog Number	515102
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr, if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Event details: in the clinical trials carried out in our company, thebd phaseal¿ protector p21 device, which is a product of your company, is used.In a clinical research center, during the drug preparation process, there were no visible particles in the lyophilized powder or the sterile solution used, while black particles were observed in the liquid mixture after mixing the powder and solution using the bd phaseal¿ protector p21 device.This situation was repeated in 6-7 different vials.Was patient or user harmed? if yes, please explain.We did not administer damaged research products to the patient.Therefore, our patients were not harmed.What medication vials is this occurring with? mk-3120 lyophilized powder for infusion 100 mg/vial: mk-3120 lyophilized powder for solution for infusion is a sterile, non-pyrogenic powder supplied in a single-use type i glass vial containing 100 mg/5 ml (20 mg/ml) of mk-3120.The product is a preservative-free, latex free solution which is essentially free of extraneous particulates.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: it was reported that black particles were observed within the vial after use of our product.Two photos and ten unused samples were provided to our quality team for investigation.The first photo shows the protector without any visible damage or related defect, while the second photo shows the vial with a particle at the bottom, confirming the reported concern.Fragmentation testing is routinely performed during manufacturing to evaluate particulate generation after ten activations.A device history record (dhr) review was completed for protector lot 2501102, and no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported concern.The results for the reported lots were reviewed and found to be within specification.Fragmentation testing was conducted on the returned products and verified the product met required specification.While phaseal needles are designed to reduce coring (fragmentation), there are several factors that may impact coring tendency.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 possible that the particle was generated during assembly of the protector onto the vial; however, without the physical sample for further evaluation, a definitive root cause cannot be established at this time.Complaints received for this device and reported condition will continue to be tracked and trended for future occurrence.
Event or Problem Description
No additional information.

• Brand Name: BD PHASEAL
• Common Device Name: PROTECTOR (P21)
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23616964
• Report Number: 3003152976-2025-00646
• Device Sequence Number: 15955299
• Product Code: ONB
• UDI-Device Identifier: 00382905151026
• UDI-Public: (01)00382905151026(11)250110(17)291231(10)2501102
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 515102
• Device Lot Number: 2501102
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown