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

Catalog Number	515302
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is cazin, bosnia.This site is not registered with the fda.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that an unspecified amount of bd phaseal¿ secondary sets c61 were found with damaged/flattened tubing before use.The following information was provided by the initial reporter: "c61 (515302) tubing was found flattened before usage.Multiple c61 was found with defect".
Additional Manufacturer Narrative
Product 515302, lot 1024992, qty 20.160, produced october 2022.Manufacturing process was conducted in accordance with document (b)(4) and all quality control activities have been performed according to quality specification (b)(4) and (b)(4).According to dhr, there were no quality notifications observed during manufacturing process related to customer complaint.After detailed investigation, it can be said that there is one potential root cause which could be connected with packaging process of subject product.During sealing process there could happen that packaging machine sliced the infusion set.This batch have been packed at packaging machine multivac idn 373.If customer provide additional information that could help to conduct more detail investigation, investigation of this customer complaint will be revised, as needed.
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
Product 515302, lot 1024992, qty 20.160, produced october 2022.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.Photographs provided displaying flattened tubing.After detailed investigation, it can be said that there is one potential root cause which could be connected with packaging process of subject product.During sealing process there could happen that packaging machine sliced the infusion set.This batch have been packed at packaging machine multivac idn 373.If customer provide additional information that could help to conduct more detail investigation, investigation of this customer complaint will be revised, as needed.
Event or Problem Description
C61 (515302) tubing was found flattened before usage.Multiple c61 was found with defect, attached pir tracker for your reference.

• Brand Name: BD PHASEAL¿ 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17726097
• Report Number: 2243072-2023-01620
• Device Sequence Number: 6399693
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2024

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: Lay User/Patient
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 515302
• Device Lot Number: 1024992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/17/2024; 01/30/2024
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 01/24/2024; 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown