MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION ADAPTER; INTRAVASCULAR ADMINISTRATION SET

Model Number	515307
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd phaseal¿ infusion adapter had an issue with foreign material/coring.The following information was provided by the initial reporter: "now they realized white fluffy particles and one grey particle in ready drug bag after used phaseal system:protector, injector and adapter.".
Additional Manufacturer Narrative
H.6.Investigation: samples received for investigation, upon visual inspection no particles or damages were observed.Fragmentation testing is performed according to procedure, to evaluate any particulates generated by the injector when mated to other components after ten activations.A device history review was performed for reported lot 2006214, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Based on the quality team's investigation, a root cause related to our manufacturing process cannot be identified at this time.
Event or Problem Description
It was reported bd phaseal¿ infusion adapter had an issue with foreign material/coring.The following information was provided by the initial reporter: "now they realized white fluffy particles and one grey particle in ready drug bag after used phaseal system:protector, injector and adapter.".

• Brand Name: BD PHASEAL¿ INFUSION ADAPTER
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12682847
• Report Number: 3003152976-2021-00704
• Device Sequence Number: 4298006
• Product Code: ONB
• UDI-Device Identifier: 00382905153075
• UDI-Public: 00382905153075
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 11/15/2021

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 Expiration Date: 05/31/2024
• Device Model Number: 515307
• Device Catalogue Number: 515307
• Device Lot Number: 2006214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2020
• 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