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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
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# 515065, batch# unknown.It was reported by customer that the membrane portion of a 515065 p20-0 protector breaking off while trying to push solution into a vial.Verbatim: customer described 2 instances of the membrane portion of a 515065 p20-0 protector breaking off while trying to push solution into a vial.
Event or Problem Description
Material# 515065.Batch# unknown.It was reported by customer that the membrane portion of a 515065 p20-0 protector breaking off while trying to push solution into a vial.Verbatim: customer described 2 instances of the membrane portion of a 515065 p20-0 protector breaking off while trying to push solution into a vial.Per customer response 23apr2024: i do not know what the lot number was of this product.The result of the break was a hazardous drug spill both times the protectors broke.I did not take any pictures the first time it broke.Both of these pictures are from the second incident.I was using it manually.We do not have the assembly fixture at this time.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: one photo was provided to our quality team for investigation.Through visual inspection, the connection stick of the protector is observed broken, verifying the reported incident.There is no other visible defect that can be identified to indicate why the breakage occurred.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including attachment and detachment testing as well as separation force.As the lot involved in this incident is unknown, a device history review could not be performed and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.Complaints received for this device and reported 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.; 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: 19174567
• Report Number: 3003152976-2024-00242
• Device Sequence Number: 7085896
• Product Code: ONB
• UDI-Device Identifier: 00382905150654
• UDI-Public: (01)00382905150654
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: 515065
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 08/28/2024
• 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