MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. SEC W/SS DC 20DP & HANGER; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10013364
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 19046017, medical device expiration date: 12/04/2022, device manufacture date: 09/16/2019.Medical device lot #: 18107352, medical device expiration date: 10/31/2021, device manufacture date: 10/30/2018.Investigation summary: seventeen 10013364 samples were received for investigation in sealed packaging; sixteen from lot 19046017 and one from lot 18107352.A visual inspection confirmed the customer's experience as dark stains and particles were found in nine of the received samples; eight from lot 19046017 and the sample from lot 18107352.The contaminants were identified on the smartsite female luer adaptor and the drip chamber barrel.Attempts to wipe away the contaminants were successful.Investigation conclusion: according with the supervisor, if a contamination is found in any of the components, the material is segregate and scraped due to the contamination.During the process revision of the subassembly process (of the drip chamber and smartsite), it was found that the machine doesn¿t touch the top of the smartsite, instead, the gripper only touches the side of the fla, disregarding the possible contamination of the machine.The process was reviewed and no issues was observed during the revision, after the revision of the process it was found that the failure mode could not be replicated, however, a quality alert was implement to warn the personnel about this issue, therefore, since no issues were found during the process the root cause could not be determinated.After the assembly in the soos machine, the sub assembly is inspected 100% by visual inspection, during this inspection it was found that the personnel check the smartsite and drip chamber assembly.It was asked to the personnel about the possible contamination in the smartsite, and they answered that they have detected but in isolated cases and when a contamination is detected the part is scrapped.
Event or Problem Description
It was reported that 17 sec w/ss dc 20dp & hangers experienced foreign matter in the fluid pathway.The following information was provided by the initial reporter: the reported feedback suggests that there are particles in packaging.
Additional Manufacturer Narrative
The following information has been corrected: g.4.Date received by manufacturer: 04/06/2020.
Event or Problem Description
It was reported that 17 sec w/ss dc 20dp & hangers experienced foreign matter in the fluid pathway.The following information was provided by the initial reporter: the reported feedback suggests that there are particles in packaging.

• Brand Name: SEC W/SS DC 20DP & HANGER
• 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: 9941456
• Report Number: 2016493-2020-00516
• Device Sequence Number: 678690
• Product Code: FPA
• UDI-Device Identifier: 10885403221927
• UDI-Public: 10885403221927
• Combination Product (Y/N): N
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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 Catalogue Number: 10013364
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/20/2020
• 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: 20191205
• Outcome Attributed to Adverse Event: Other