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

Catalog Number	515302
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	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal had foreign matter.The following information was provided by the initial reporter: black stain is observed on the part and outer packaging is broken.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
Sku 515302, lot: 1029206, qty: (b)(4) pcs, was produced in april 2024.According to dhr, there were no quality notifications observed during manufacturing process related to mentioned issue.Manufacturing process was conducted in accordance with document (b)(4) and all quality control activities have been performed according to quality specification 10-0160.The sample is not available, but customer did provide pictures, and the customer complaint is confirmed.Risk assessment have been performed based on document (b)(4) (pfmea related to packaging process), and it can be confirmed that this failure mode has been included into mentioned document, and appropriate risk control have been set up (10-0255 - control specification).The retain sample was inspected and no defects were found on the packaging or components.During the investigation that was carried out on the cazin site, it was not determined what caused this kind of defect.During the packaging process, it may happen that the foil is damaged, but these damages are different and without contamination.The image does not allow us to recognize and identify the exact substance with which the sample was contaminated, which further limits the investigation.

• Brand Name: BD PHASEAL
• 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; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20708335
• Report Number: 2243072-2024-01137
• Device Sequence Number: 15928735
• Product Code: ONB
• UDI-Device Identifier: 00382905153020
• UDI-Public: (01)00382905153020(10)1029206
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: 515302
• Device Lot Number: 1029206
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 02/19/2025
• 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