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

Catalog Number	515065
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	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Short description drug contamination on the membrane during the preparations of hazardous drugs there was a liquid contamination on the membrane when did the incident occur? during use additional information: can you provide the batch number of the defective product? 2406408, 31/05/2026.Confirm the number of affected products.Have there been any impacts on patients (serious injuries, medical interventions, need to change treatment)? no we would like you to confirm whether samples are available for investigation.If so, you can specify whether the samples are: - not used (before use) yes with no-drug colouring solution (methylene blue).
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.
Event or Problem Description
Short description drug contamination on the membrane.During the preparations of hazardous drugs there was a liquid contamination on the membrane.When did the incident occur? during use.Please follow up with the customer and verify: was the liquid warned before using the device or later? later.If later, which drug was used? was this the first withdrawal from the vial or were multiple doses taken? doxorubicin, cyclophosphamide, paclitaxel, fluorourcail, irinotecan, docetaxel, carboplatin, bendamustine.Some were contaminated before the first withdrawal, others from the second.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: two injectors and two protectors assembled onto a vial with blue liquid inside, were provided to our quality team for investigation.Upon visual inspection, the membranes are observed to have been punctured and blue stains were observed on the membrane.Functional testing was performed on the returned samples, after passing liquid through the system and disconnecting the injector from the protector, the membrane was noted to be slightly wet.A device history review was performed for injector lot 2310305 and protector lot 2406408, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Leakage and pressure testing is performed for all lots during manufacturing to ensure the quality of the membrane.Results were reviewed for lots 2310305 and 2406408, all results were found to be within specification.Retained samples of both lots were used for additional evaluation.Functional testing was performed, penetrating the protectors along with sample injectors ten times, all results were found to be acceptable with no leaks identified.The performance of the sealing membrane is reduced after multiple perforations and extended activation time, the membranes are designed to be punctured up to ten times.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.It is possible the staining occurred due to pressure within the system when puncturing the membrane.Complaints received for this device and reported condition will continue to 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.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20168363
• Report Number: 3003152976-2024-00498
• Device Sequence Number: 8069657
• Product Code: ONB
• UDI-Device Identifier: 00382905150654
• UDI-Public: (01)00382905150654(11)240606(17)260531(10)2406408
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 515065
• Device Lot Number: 2406408
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 01/09/2025
• 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