MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. Y EXT W/VLV PORTS & 2 SLD CLP; INTRAVASCULAR ADMINISTRATION SET

Model Number 20019E

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that y ext w/vlv ports & 2 sld clp had a loose connection on 2 occasions.The following information was provided by the initial reporter: event 2 originated from bag 10: customer sent one used 20019e, lot number: 20045838.Attached to one used 3ml bd syringe, lot number: 0127937, exp: 2023-04-30.Customer sent one used 20019e, lot number: 20045838; curos cap attached to smartsite.Attached to one used 20038e, lot number: unknown.The customer attached a sticky note stating, "both of these bifurcats just "spinned" when i (didn't lock/tighten) tried to connect my ivf to my piv-had to use a trifurcate.".

Event Description

It was reported that y ext w/vlv ports & 2 sld clp had a loose connection on 2 occasions.The following information was provided by the initial reporter: event 2 originated from bag 10: customer sent one used 20019e, lot number: 20045838 attached to one used 3ml bd syringe, lot number: 0127937, exp: 2023-04-30 customer sent one used 20019e, lot number: 20045838 curos cap attached to smartsite attached to one used 20038e, lot number: unknown" the customer attached a sticky note stating "both of these bifurcats just "spinned" when i (didn't lock/tighten) tried to connect my ivf to my piv-had to use a trifurcate.

Manufacturer Narrative

Two samples of model 20019e, lot 20035838 and one sample of model 20038e were submitted for quality investigation.The customer submitted a complaint that the bifurcats just "spined." the samples were visually inspected for any damages to each component.There were not visual indications of damages for each of the components.Each connection was checked for "spinning," but the issue could not be replicated.The samples were then filled with blue dye and checked for leakage using alaris pumping pressure.There were no leaks found at any of the smartsite connections or luer connections for each device.A device history record review for model 20019e lot number 20045838 was performed.The search showed that a total of 17,283 units in 1 lot number was built on 13apr2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Based on the inability to replicate the failure mode submitted by the customer, root cause analysis could not be conducted.

• Brand Name: Y EXT W/VLV PORTS & 2 SLD CLP
• Type of Device: 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: 10646162
• MDR Text Key: 210658936
• Report Number: 9616066-2020-20032
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 27613203013813
• UDI-Public: 27613203013813
• Combination Product (y/n): N
• PMA/PMN Number: K061285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

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
• Device Operator: Other
• Device Expiration Date: 04/13/2023
• Device Model Number: 20019E
• Device Catalogue Number: 20019E
• Device Lot Number: 20045838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other