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

Model 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	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the add-on burette ss vlv ps ball vlv was blocked and had flow issues while infusing the medication.The following information was provided by the initial reporter: "the injection port of the burette was not working properly.The nurse try to add/inject medication into the burette but the medication could not be pushed into the system.Nurse tried manipulating the clamps etc but made no difference.".
Event or Problem Description
It was reported that the add-on burette ss vlv ps ball vlv was blocked and had flow issues while infusing the medication.The following information was provided by the initial reporter: "the injection port of the burette was not working properly.The nurse try to add/inject medication into the burette but the medication could not be pushed into the system.Nurse tried manipulating the clamps etc but made no difference.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 5/13/2021.H.6.Investigation: one 82115e sample was received without packaging; residual fluid was present in the set.The lot number of the affected product was not available, however evaluation of the laser inscribed smartsite® id determined the likely lot numbers for the affected product to be either 20106171, 20106172, 20106173, 20106174 or 20106175.No additional information was available to assist the investigation in this instance.A visual inspection of the returned product identified that the tubing below the spike component had been cut and the spike had also been removed.A closer inspection of the smartsite component identified that the tubing connecting the smartsite to the top of the burette had a significant kink in it.Attempts were then made to access the smartsite component using bd syringes from bd stock; in each instance no occlusion or flow restriction was observed.A review of the production records for lots 20106171, 20106172, 20106173, 20106174 and 20106175 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The customer's experience of occlusion could not be replicated in this instance as no flow restriction or occlusion was identified during attempts to access the smartsite.It was however noted that the tubing below the smartsite was kinked, however it could not be determined if this may have contributed to the customer's experience or occurred during transportation for testing.

• 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: 11918078
• Report Number: 9616066-2021-51225
• Device Sequence Number: 923776
• Product Code: FPA
• UDI-Device Identifier: 37613203009585
• UDI-Public: 37613203009585
• 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): 06/15/2021

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 Model Number: 82115E
• Device Catalogue Number: 82115E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1