MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP LOW SORBING NO PORTS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	11426964
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	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).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 the gem v/nv 20dp low sorbing no ports experienced foreign matter contamination.The following information was provided by the initial reporter: material no: 11426964, batch no: 20085878.We have noticed some red spray substance in the chamber of the tubing today.
Additional Manufacturer Narrative
H.6.Investigation: three samples were returned for quality investigation.The customer complaint of foreign matter was verified by visual inspection.Under magnification, particles of red foreign matter can be seen embedded into the drip chamber body material.A device history record review for model: 11426964, lot number: 20085875 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 this issue is that the material appears to be degraded material from the same material that the drip chamber is composed from.This issue indicates an error during the manufacturing of the drip chamber from the supplier.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of foreign matter with lot#: 20085878 regarding item#: 11426964.
Event or Problem Description
It was reported that the gem v/nv 20dp low sorbing no ports experienced foreign matter contamination.The following information was provided by the initial reporter: material no: 11426964, batch no: 20085878.We have noticed some red spray substance in the chamber of the tubing today.

• Brand Name: GEM V/NV 20DP LOW SORBING NO PORTS
• 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: 11264057
• Report Number: 9616066-2021-50143
• Device Sequence Number: 3256480
• Product Code: FPA
• UDI-Device Identifier: 10885403232367
• UDI-Public: 10885403232367
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 02/23/2021

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: 08/08/2023
• Device Catalogue Number: 11426964
• Device Lot Number: 20085878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1