MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. NDLELESS VLV ADPT ARTERIAL; INTRAVASCULAR ADMINISTRATION SET

Model Number	2000EA
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2020
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.(b)(4).
Event or Problem Description
It was reported that 2 needles vlv adpt arterial experienced device damage/deformation.The following information was provided by the initial reporter: material no: 2000ea batch no: 20076485 the base of the 200ea cracked when mounted on mechanical pump 2 times.
Event or Problem Description
It was reported that 2 ndleless vlv adpt arterial experienced device damage/deformation.The following information was provided by the initial reporter: material no: 2000ea, batch no: 20076485.The base of the 200ea cracked when mounted on mechanical pump 2 times.
Additional Manufacturer Narrative
H.6.Investigation: a complaint of component damage was received from the customer.Two samples were returned for investigation.One used sample was investigated, and through visual inspection the customer complaint was confirmed.The threads of the component were found to be jagged and uneven.The component was then connected to another set and it was able to maintain a connection.The unused sample was then investigated and no damages could be found.It was then connected to another set and a leakage test was performed.No leaks were observed on the unused sample.A device history record review for model 2000ea lot number 20076485 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of component damage with lot #20076485 regarding item #2000ea.Possible root causes for this failure include error in the manufacturing process as well as excessive force applied to component during use.H3 other text : see h.10.

• Brand Name: NDLELESS VLV ADPT ARTERIAL
• 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: 10703504
• Report Number: 9616066-2020-20110
• Device Sequence Number: 17177474
• Product Code: FPA
• UDI-Device Identifier: 27613203021689
• UDI-Public: 27613203021689
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/30/2020

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: 07/14/2023
• Device Model Number: 2000EA
• Device Catalogue Number: 2000EA
• Device Lot Number: 20076485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1