MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES; INTRAVASCULAR ADMINISTRATION SET

Model Number	515306
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 7 bd phaseal¿ iv bag/line access devices experienced flow issues.The following information was provided by the initial reporter: air in the system.We have had a big problem with the new infusion sets from in combination with phaseal's adapter for antibiotic mixing the last few days.When using these two together, the entire drip chamber fills with air and spreads out into the drip line.We have had no problems with air intake when the unit is used alone for infusions.It is an automatic self-regulating valve on the units that should only be open for infusions from a glass bottle.We have of course tried both with the valve open and closed but with the same result.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 10-feb-2023.H6: investigation summary: ten unused samples were provided to our quality team for investigation.The products were visually inspected, there was no damage or other defects observed on any of the infusion adapters.A device history review was performed for reported lot 2202222, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that the product is free from damage and all critical dimensions are within specification.All returned samples underwent these evaluations and product was verified to meet required specification, including proper spike length and diameter.Based on the available information, we cannot identify a root cause related to our product or manufacturing process at this time.H3 other text : see h10.
Event or Problem Description
It was reported that 7 bd phaseal¿ iv bag/line access devices experienced flow issues.The following information was provided by the initial reporter: air in the system.We have had a big problem with the new infusion sets from in combination with phaseal's adapter for antibiotic mixing the last few days.When using these two together, the entire drip chamber fills with air and spreads out into the drip line.We have had no problems with air intake when the unit is used alone for infusions.It is an automatic self-regulating valve on the units that should only be open for infusions from a glass bottle.We have of course tried both with the valve open and closed but with the same result.

• Brand Name: BD PHASEAL¿ IV BAG/LINE ACCESS DEVICES
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15761336
• Report Number: 3003152976-2022-00501
• Device Sequence Number: 15502088
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: 00382905153068
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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: 01/31/2026
• Device Model Number: 515306
• Device Catalogue Number: 515306
• Device Lot Number: 2202222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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