MAUDE Adverse Event Report: BECTON DICKINSON BD SECONDARY SET C61; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515302
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd secondary set c61 leaked during the chemotherapy check by the pharmacist, a leak of chemo (doxorubicin) leaked from the infusion bag adapter (the patient's bag had to be re-prepared).
Additional Manufacturer Narrative
Product 515302, lot 1030249, qty (b)(4) pcs, was produced in sep 2024.Manufacturing process was conducted in accordance with document 15-0137 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 not been received.Based on the picture and video provided from the customer, it can be confirmed customer experience.This defect is classified as c4.2 - leakage, which causes risk for patient and/or user.Retain sample have been examined, and it can be confirmed that all components are present.There is no defect observed during this examination.During assembly, the product undergoes a 100% leak inspection, and this is defined in procedure (b)(4).If the leaking product is detected in the 100% testing process, it will be separated as scrap.During the inspection of retained sample it was established that the system does not leak.The exact defect cannot be determined based on the image or video.It cannot be seen whether there is a leak at the connection of the hose and the spike, whether the spike is damaged, or some other defect caused the leak.
Event or Problem Description
Can you confirm the approximate location of the leakage on the adapter? -the leakage was observed at the junction between the transparent tubing and the body of the adapter, where a white ergo can be seen to which the tubing is attached.Can you confirm that the adapter has suffered any obvious damage? -there's no obvious damage to the adapter! can you confirm that you are able to provide our team with an image or video of the leakage as it occurs? -we'll try to send this to you, but there's no guarantee of results! can you confirm that the same adapter was used for both prepared bags? -yes, we've used the same adapters on other preparations without noticing any leakage; fortunately! **no additional information received.

• Brand Name: BD SECONDARY SET C61
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21048098
• Report Number: 2243072-2024-01272
• Device Sequence Number: 18263763
• Product Code: ONB
• UDI-Device Identifier: 00382905153020
• UDI-Public: (01)00382905153020(10)1030249
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/17/2025

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: 1030249
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 01/28/2025
• 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