MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. T-CONN W/LUER SLIP ADPT; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20051E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Intimal Dissection (1333); No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Thirty-one 20051e samples were received for investigation; twenty-four samples were received in sealed packaging from lot 19065384, two samples were received in open packaging from lot 19065384 and five samples were received without packaging.No fluid was present in the lines.A visual inspection of all of the returned samples identified the smartsite component to be oval shaped.Pressure testing of the samples received without packaging confirmed the customer's experience as leakage was observed from the oval smartsites.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 19065384 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Please note, the cause of this issue is exposure of the smartsite® to an external heat source that brings the component temperature above 60°c.The piston head of the smartsite® is oval-shaped therefore when the round female luer adaptor (fla) component is placed over it, the piston opening is squeezed shut in order to create a seal.Under excessive heat conditions, the fla material can soften, and as the piston pushes back on the inside, it can reshape the fla to conform to the original oval-shape of the piston head.A review of the manufacturing process, bd storage conditions, and sterilization process has not found a potential root cause for this level of excess heat.A review of the customer feedback database indicates that there is no general increased trend for oval smartsite® valves.It is possible that there is a local environmental factor that has caused the product to reach the elevated temperature required to cause this issue (e.G.During storage or transit).
Event or Problem Description
It was reported that 32 t-conns w/luer slip adpt experienced leakage.The following information was provided by the initial reporter: fluid was coming out from the deformed oval connector end.The smartsite needle-free connector end is clearly deformed into oval shape (should be round shape).Fluid was coming out from the deformed oval connector end.Affected quantity: 32 ea.
Additional Manufacturer Narrative
The following information has been updated: h.6.Patient codes: 2199 -no consequence or impact to patient h3 other text : see h.10.
Event or Problem Description
It was reported that 32 t-conns w/luer slip adpt experienced leakage.The following information was provided by the initial reporter: fluid was coming out from the deformed oval connector end.The smartsite needle-free connector end is clearly deformed into oval shape (should be round shape).Fluid was coming out from the deformed oval connector end.Affected quantity: 32 ea.

• Brand Name: T-CONN W/LUER SLIP ADPT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 9930960
• Report Number: 9616066-2020-01183
• Device Sequence Number: 2900960
• Product Code: FPA
• UDI-Device Identifier: 07613203012331
• UDI-Public: 07613203012331
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/12/2022
• Device Catalogue Number: 20051E
• Device Lot Number: 19065394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 20051E, 20200310.
• Outcome Attributed to Adverse Event: Other