MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P20-O; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515064
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	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Material#: 515064, batch number#: 2309405.It was reported by customer that black spotting on end of p20-o vial spike by rubber cover- this is urgent, this is the second lot number, the account is thinking of going back to using needle and syringe, they are worried that this is mold.The protector was not used, as the tech noticed the spotting upon opening the packaging and taking the green cap off.
Event or Problem Description
Material#: 515064.Batch number#: 2309405.It was reported by customer that black spotting on end of p20-o vial spike by rubber cover- this is urgent, this is the second lot number, the account is thinking of going back to using needle and syringe, they are worried that this is mold.The protector was not used, as the tech noticed the spotting upon opening the packaging and taking the green cap off.
Additional Manufacturer Narrative
Pr 10078514 follow up mdr for device evaluation: both the physical samples along with photos were provided to our quality team for investigation.Through visual inspection, a stain is observed on the protector sleeve.Further evaluation determined the stain is grease.A device history review was performed for reported lot 2309405, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.Retained samples of the reported lot were used for additional evaluation.All products were inspected, no foreign matter or grease stains were observed on any of the devices.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, no issues related to this incident were identified.Machines undergo routine cleaning and maintenance according to procedure, all inspection records verify that all quality processes were carried out normally.While we could not identify a direct issue, it was determined the grease stain likely occurred during the molding process as a result of the product coming into contact with a specific part of the equipment that must be greased for operation.Manufacturing personnel have been notified of this incident.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.

• Brand Name: PROTECTOR P20-O
• 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 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19200966
• Report Number: 3003152976-2024-00253
• Device Sequence Number: 18141813
• Product Code: ONB
• UDI-Device Identifier: 00382905150647
• UDI-Public: (01)00382905150647
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181221
• 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): 05/20/2024

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 515064
• Device Lot Number: 2309405
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown