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

Catalog Number	515302
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd secondary set c61 was in an open unit packaging c61 not sealed in sterile packaging.
Additional Manufacturer Narrative
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 10289115 qty (b)(4), was produced in mar 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 15-0137 and all quality control activities have been performed according to quality specification 10-0255 and 10-0160.Based on provided evidence (picture from customer) can be concluded that this damage was caused by packaging machine during packaging process on cazin site.After inspection of the retained sample, it was determined that there was no damage on the tube or any other nonconformity.Risk assessment have been performed based on document (b)(4) (pfmea related to packaging process), and it can be confirmed that this failure mode (tube damage - pinched set) have been included into mentioned document, and appropriate risk control have been set up (10-0255 - control specification).Coiling process of products and placing products in nests in packaging machine is performed manually, and packaging process in transport boxes is also manually performed.Operators should have identified and separated the product when packing it into the cargo box.This case can be attributed to the operator's lack of concentration.In order to prevent the repetition of this defect, sensors on packaging machine will be implemented.
Event or Problem Description
No additional information provided.

• 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: 21366210
• Report Number: 2243072-2025-00074
• Device Sequence Number: 18255922
• Product Code: ONB
• UDI-Device Identifier: 00382905153020
• UDI-Public: (01)00382905153020(10)1028915
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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: 1028915
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/15/2025
• 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