MAUDE Adverse Event Report: BECTON DICKINSON BD SECONDARY SET C61; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515302
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd secondary set c61 had luer lock breakage.The following information was provided by the initial reporter: short description a piece was chipped from the end of the tube (connection part to main iv line) pharmacist noticed during usage, that a piece was chipped from the end of the tube (connection part to main iv line).When did the incident occur? during use.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Sku 515302, lot: 1029205, qty (b)(4)-080 pcs, was produced in april 2024.According to dhr, there were no quality notifications observed during manufacturing process related to mentioned issue.Manufacturing process was conducted in accordance with document (b)(4) and all quality control activities have been performed according to quality specification 10-0160 and 10-0255.According to dhr, there were no quality notifications observed during manufacturing process related to customer complaint.Sample has been received.Based on the performed inspection on received sample on cazin site provided from the customer, it can be confirmed customer experience.This defect is classified as c35 - imperfect assembly, incomplete which causes risk for patient and/or user.After the inspection, it is concluded that the damage to the component did not occur in cazin, because the damage is curved and smooth, without unevenness.In the image of the sample that is slightly damaged, creases are present, and it is evident that the damage is not similar to the damage reported by the customer.Cazin requested investigation from external supplier.Based on performed investigation, conclusion is that this is isolated case.Over 54 million units have been produced over the last 3 years, and there has been no complaint about this defect.
Event or Problem Description
No additional information provided.

• Brand Name: BD SECONDARY SET C61
• 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): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana NJ 22244
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20539428
• Report Number: 2243072-2024-01073
• Device Sequence Number: 15524848
• Product Code: ONB
• UDI-Device Identifier: 00382905153020
• UDI-Public: (01)00382905153020(10)10029205
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 02/18/2025

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 Catalogue Number: 515302
• Device Lot Number: 10029205
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 02/19/2025
• 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