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	05/25/2021
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 that the add-on burette ss vlv ps ball vlv iv port was blocked/occluded and resulted in flow issues during use.The following information was provided by the initial reporter: "iv port not working, appears to be blocked or faulty.".
Event or Problem Description
It was reported that the add-on burette ss vlv ps ball vlv iv port was blocked/occluded and resulted in flow issues during use.The following information was provided by the initial reporter: "iv port not working, appears to be blocked or faulty.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-06-08.H6: investigation summary one 82115e sample was received without packaging for investigation; the customer feedback indicates that the affected sample was from lot 20106175.Residual fluid was present inside the sample; no connecting products were returned to assist the investigation.A visual inspection of the returned sample did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing was performed by connecting a retained 50ml bd plastipak syringe from stock to the smartsite component above the burette; no flow restrictions or occlusions were identified.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned sample did not identify any product defects that could have contributed to the customer¿s experience.A review of the production records for lot 20106175 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Previous complaints for occlusions to the smartsite have been related to features on the surface of the male luer of the connecting products.These features include flash or a raised edge to the tip of the male luer which have previously been shown to intermittently lead to restricted flow due to them pinching the blue piston of the smartsite and not allowing it to open.This can sometimes be resolved by disconnecting and reattaching the same luer connection which may reposition the luer against the piston and improve the flow, or alternatively by changing the connecting male luer.In this instance the connecting product in use at the time of the customer's experience was not available for investigation and therefore it has not been possible to confirm if this may have contributed to the customer's experience.Capa 1998036 has been initiated.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the 82115e product.H3 other text : see h10.

• 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: 12054624
• Report Number: 9616066-2021-51373
• Device Sequence Number: 14318992
• 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): 06/28/2021

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 Expiration Date: 10/30/2023
• Device Model Number: 82115E
• Device Catalogue Number: 82115E
• Device Lot Number: 20106175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1