MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GRAVITY SET 60DP CHECKVALVE 3 SMS; INTRAVASCULAR ADMINISTRATION SET

Model Number	42433E
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/12/2020
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.Fda device problem code: 1354, 2944.Fda patient problem code: 2645.
Event or Problem Description
It was reported that the gravity set 60dp checkvalve 3 sms luer lock was found to be "flipped the wrong way".The following information was provided by the initial reporter: "per the customer, the third luer lock is flipped the wrong way.".
Event or Problem Description
It was reported that the gravity set 60dp checkvalve 3 sms luer lock was found to be "flipped the wrong way".The following information was provided by the initial reporter: "per the customer, the third luer lock is flipped the wrong way.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 11/30/2020.H.6.Investigation: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of misassembly with lot #20015252 regarding item #(b)(4).One sample was received for quality investigation.The customers complaint of misassembly was verified by visual inspection.The customer statement that the third luer lock was inverted was incorrect, however, the third smartsite y-site is the component that was inverted on the assembly.A device history record review for model 42433e lot number 20015252 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issue is a misassembly at the manufacturing facility.

• Brand Name: GRAVITY SET 60DP CHECKVALVE 3 SMS
• 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: 10906506
• Report Number: 9616066-2020-20445
• Device Sequence Number: 16867791
• Product Code: FPA
• UDI-Device Identifier: 50885403235359
• UDI-Public: 50885403235359
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 12/07/2020

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: 01/14/2023
• Device Model Number: 42433E
• Device Catalogue Number: 42433E
• Device Lot Number: 20015252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1