MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	22003E-07
Medical Device Problem Code	Flushing Problem (1252)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device lot #: 21129217, medical device expiration date: 2022-12-09, device manufacture date: 2021-12-09.Medical device lot #: 21119801, medical device expiration date: 2022-11-02, device manufacture date: 2021-11-02.Medical device lot #: 21119800, medical device expiration date: 2022-11-02, device manufacture date: 2021-11-02.Medical device lot #: 21089075, medical device expiration date: 2022-08-18, device manufacture date: 2021-08-18.Medical device lot #: 21109127, medical device expiration date: 2022-10-26, device manufacture date: 2021-10-26.Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.
Event or Problem Description
It was reported that there are 159 bd alaris smartsite extension set that experienced flushing issues.The following information was provided by the initial reporter: flushing issues; smartsite not opening.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 15-apr-2022.H6: investigation summary: five samples (model #22003e-07, lot #21089075), 24 samples (model #22003e-07, possible lots #21089073, #21129217, #21109127, #21119799, #21119802), one sample (model #22003e-07, lot #21109127), 13 samples (model #22003e-07, lot #21129217), 75 samples (model #22003e-07, lot #21119801), 41 samples (model #22003e-07, lot #21119800), were returned by the customer.It was reported that the smartsite is not opening and they are experiencing flushing issues.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The samples were connected to a cut off syringe tip to check that the fluid path is in an activated position/open when connected to a syringe.The samples were then attempted to be flushed with water using a 10ml bd syringe to confirm an open fluid path.The fluid paths of 36 samples were open and those samples were able to be flushed.The failure was unable to be replicated in these samples.The fluid paths of 5 samples were not open and were unable to be flushed.The customer complaint can be verified in these samples.A root cause was unable to be determined.Due to an increase in incidents of this failure mode, a trend for this occlusion issue has been identified for this product line, a capa (corrective action preventative action) 1998036 has been initiated, and a team has been assembled in order to investigate the issue.A device history record review for model 22003e-07 lot numbers 21119801, 21119800, 21129217, 21089075, 21109127, was performed.
Event or Problem Description
It was reported that there are 159 bd alaris smartsite extension set that experienced flushing issues.The following information was provided by the initial reporter: flushing issues; smartsite not opening.

• Brand Name: BD ALARIS SMARTSITE EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14166725
• Report Number: 9616066-2022-00459
• Device Sequence Number: 12018008
• Product Code: FPA
• UDI-Device Identifier: 50885403242043
• UDI-Public: 50885403242043
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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 Model Number: 22003E-07
• Device Catalogue Number: 22003E-07
• Device Lot Number: SEE H10
• 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: 04/05/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 07/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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