MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL; PROTECTOR (P50)

Catalog Number	515105
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
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: it was reported that hair found inside the chamber.Found during use.Neither patient nor user were harmed.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: two photos and one video were provided to our quality team for investigation.Upon visual inspection, a hair was observed within the expansion chamber, verifying the reported concern.A device history review was completed for lot 2503103.No deviations or non-conformances were identified during manufacturing that could have contributed to this issue.Three retained samples from the same lot were examined, and no hair or other contamination was found in any of the units.This product is manufactured in a clean room maintained under positive pressure to minimize the introduction of foreign material.Final products in this manufacturing line, for this reference, are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures, no issues were identified during these inspections.All individuals are required to follow proper gowning procedures before entering the room, including hair protection.Although no direct issues were identified, we have identified the root cause as related to personnel failing to follow proper gowning procedures, allowing a hair to enter the product during assembly.Manufacturing personnel have been notified of this incident to increase awareness of this matter.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD PHASEAL
• Common Device Name: PROTECTOR (P50)
• 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 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23974618
• Report Number: 3003152976-2025-00699
• Device Sequence Number: 4565779
• Product Code: ONB
• UDI-Device Identifier: 00382905151057
• UDI-Public: (01)00382905151057(11)250310(17)300228(10)2503103
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: 2503103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown