MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P55; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515117
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This is a complaint about leakage.It was reported that when the p55 was connected to a vial, and the injector was connected, the vial was tilted to make adjustments, the chemical solution leaked.
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.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: one protector connected to a vial was provided to our quality team for investigation.Through visual inspection, a leak between the protector and vial was observed.Upon further evaluation, it was noted the protector needle did not properly penetrate the stopper of the vial, it was off center causing damage and preventing a secure connection.The protector was reconnected using the assembly fixture and functional testing was performed again, no leakage outside of the system was observed.A device history review was performed for reported lot 2312114, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples of the reported lot were used for additional evaluation.Functional testing was performed, connecting the protectors to a vial, injector, and syringe per the instructions for use provided with the product.All protectors were properly connected, liquid could move through the system without issue and no leakages occurred.Based on our investigation, we are not able to identify a root cause related to the manufacturing process at this time.It was identified the protector was not properly attached, resulting in the leak reported.The protector must be attached completely vertical to the vial.The m12 assembly fixture is recommended to ease the connection of the protector to the vial and must be used in a slow and consistent motion.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: PROTECTOR P55
• 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19810102
• Report Number: 3003152976-2024-00429
• Device Sequence Number: 8348922
• Product Code: ONB
• UDI-Device Identifier: 00382905151170
• UDI-Public: (01)00382905151170
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130197
• 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): 12/13/2024

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 Catalogue Number: 515117
• Device Lot Number: 2312114
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown