MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P53; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515107
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When blending antibiotics pip/taz its leaking between the vial of the bottle and the protector.When did the incident occur? during use.
Additional Manufacturer Narrative
(b)(4).Initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a0504 - leak / splash.Patient problem code: f24 - insufficient information.
Event or Problem Description
Additional information: the patient was not harmed and the protector is attached manually 2 there is no sample available.When blending antibiotics pip/taz its leaking between the vial of the bottle and the protector.When did the incident occur? - during use.1 the protector is attached manually.2 there is no sample available.I have not got any answer from the customer about the lotnumber the patient was not harmed.
Additional Manufacturer Narrative
(b)(4) - follow up mdr for additional information.Annex code e updated from e2401 to e2403 - no clinical signs, symptoms or conditions annex code f updated from f24 - insufficient information to f26 - no health consequences or impact.No photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause at this time.The m12 assembly fixture is recommended to ease the connection of the protector to the vial.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: PROTECTOR P53
• 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): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18072862
• Report Number: 3003152976-2023-00488
• Device Sequence Number: 7593827
• Product Code: ONB
• UDI-Device Identifier: 00382905151071
• UDI-Public: (01)00382905151071
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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: 515107
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown