MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. ADD-ON BURETTE SS VLV PS BALL VLV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	82115E
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that add-on burette ss vlv ps ball vlv had flow issues.The following information was provided by the initial reporter: unable to add medication to the burette using the medication port.Different syringes used with same result.
Event or Problem Description
It was reported that add-on burette ss vlv ps ball vlv had flow issues.The following information was provided by the initial reporter: unable to add medication to the burette using the medication port.Different syringes used with same result.
Additional Manufacturer Narrative
H.6.Investigation: a 82115e sample was received for investigation with residual fluid present inside the set; no packaging was received with the sample, however a review of the laser id from the smartsite component confirmed a possible lot number to be either 20106171, 20106172, 20106173, 20106174 or 20106175.A visual inspection of the 82115e sample did not identify any signs of damage or manufacturing defect which could have contributed to the customer's experience; functional testing was performed by connecting a 50ml bd plastipak syringe from stock to the smartsite component and flushing with fluid; no occlusion or flow restriction was identified during testing.A review of the production records for each of the potential lots did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.It was not possible to confirm the root cause of the reported issue in this instance.Testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.

• Brand Name: ADD-ON BURETTE SS VLV PS BALL VLV
• 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
• MDR Report Key: 11441154
• Report Number: 9616066-2021-50398
• Device Sequence Number: 11765825
• Product Code: FPA
• UDI-Device Identifier: 07613203009577
• UDI-Public: 07613203009577
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K780130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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: Other
• Device Catalogue Number: 82115E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1