MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD PHASEAL; SECONDARY SET C61

Catalog Number	515302
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal package seal was compromised, leading to tubing damage.The following information was provided by the initial reporter: "user opened a new set of 515302 and found out the tubing is damaged." additional information received on 12-dec-2021: "just confirmed with user, the tubing was damaged due to the seal.The seal compressed onto the tubing.".
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.G.1.Franklin lakes has been listed as the manufacturer.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Product 515302, lot 1025467 qty (b)(4) was produced in january 2023.According to dhr, there were no quality notifications observed during manufacturing process.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 customer report, one damaged sample is reported.Based on provided evidence (video 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 bh-pfmea-pa001 (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, a visual instruction vi-002-2024 was created in which potential defects on the packaging are shown, including damaged tube by seal.All operators are trained on these instructions.
Event or Problem Description
No additional information provided.

• Brand Name: BD PHASEAL
• Common Device Name: SECONDARY SET C61
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18380338
• Report Number: 2243072-2023-02228
• Device Sequence Number: 7797683
• Product Code: ONB
• UDI-Device Identifier: 00382905153020
• UDI-Public: (01)00382905153020
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2024

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: Other
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: 515302
• Device Lot Number: 1025467
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 02/11/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown