MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. TRI-PORT EXT CHK VLV W/3 VP, 7 DAY; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20062E
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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.(b)(4).
Event or Problem Description
It was reported that the tri-port ext chk vlv w/3 vp, 7 day central line was blocked bidirectionally during use.The following information was provided by the initial reporter: "the central line with filter or one way valve is blocked bidirectionally, and therefore useless.".
Event or Problem Description
It was reported that the tri-port ext chk vlv w/3 vp, 7 day central line was blocked bidirectionally during use.The following information was provided by the initial reporter: "the central line with filter or one way valve is blocked bidirectionally, and therefore useless.".
Additional Manufacturer Narrative
H.6.Investigation: one 20062e7d sample from lot 18085876 was received for investigation in opened packaging; residual fluid was present within the sample.A visual inspection of the sample did not identify signs of damage or manufacturing defects which could have contributed to the customer's experience.The sample was subjected to functional testing by attempting to flush each line with fluid; the customer's experience was confirmed as a complete occlusion was identified at the smartsite component from the middle infusion line.A closer analysis appeared to indicate the presence of residual solvent in the piston of the affected smartsite.An excessive amount of solvent could have been applied to the tubing joint during the assembly process which inadvertently reached the piston of the smartsite causing it to occlude.This is a manual process and is likely to have occurred due to human error.A review of the production records for lot 18085876 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.H3 other text : see h.10.

• Brand Name: TRI-PORT EXT CHK VLV W/3 VP, 7 DAY
• 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 22244 ; MX 22244
• MDR Report Key: 10909919
• Report Number: 9616066-2020-20476
• Device Sequence Number: 14204520
• Product Code: FPA
• UDI-Device Identifier: 07613203011853
• UDI-Public: 07613203011853
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: 08/10/2021
• Device Catalogue Number: 20062E
• Device Lot Number: 18085875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1