MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MICRO EXT SET W/1 SS VLV; INTRAVASCULAR ADMINISTRATION SET

Model Number	10010983
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that micro ext set w/1 ss vlv tubing leaked.The following information was provided by the initial reporter: material no.: 10010983, lot no.: 20055744.It was reported that there was leakage within the tubing set.At 1400 it was discovered that patient's piv was leaking.Upon closer assessment, the extension ("t-connector") that attaches to the hub of the iv was leaking where the rigid part of the tubing near the valve-end meets the flexible portion of the tubing.The tubing extension was able to be replaced, but after redressing the piv the insertion site started leaking.The iv ultimately had to be removed, leaving the patient with no way to receive incompatible meds or blood products.Vat team called to assess for new iv site, but none found.Picc team consulted, but unable to place until tomorrow am.Picu team aware.The iv and extension were 5 weeks old.The iv going bad was likely at this point, regardless, and discussions could have been had regarding obtaining more reliable access.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.A device history record review for model 10010983 lot number 20055744 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.See h.10.
Event or Problem Description
It was reported that micro ext set w/1 ss vlv tubing leaked.The following information was provided by the initial reporter: material no.: 10010983 lot no.: 20055744 it was reported that there was leakage within the tubing set.Verbatim: at 1400 it was discovered that patient's piv was leaking.Upon closer assessment, the extension ("t-connector") that attaches to the hub of the iv was leaking where the rigid part of the tubing near the valve-end meets the flexible portion of the tubing.The tubing extension was able to be replaced, but after redressing the piv the insertion site started leaking.The iv ultimately had to be removed, leaving the patient with no way to receive incompatible meds or blood products.Vat team called to assess for new iv site, but none found.Picc team consulted, but unable to place until tomorrow am.Picu team aware.The iv and extension were 5 weeks old.The iv going bad was likely at this point, regardless, and discussions could have been had regarding obtaining more reliable access.

• Brand Name: MICRO EXT SET W/1 SS 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 22244 ; MX 22244
• MDR Report Key: 10694549
• Report Number: 9616066-2020-20089
• Device Sequence Number: 3570507
• Product Code: FPA
• UDI-Device Identifier: 50885403233577
• UDI-Public: 50885403233577
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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
• Operator of Device: Other
• Device Expiration Date: 05/29/2023
• Device Model Number: 10010983
• Device Catalogue Number: 10010983
• Device Lot Number: 20055744
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 10/17/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other