MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D LOW SORB; INTRAVASCULAR ADMINISTRATION SET

Model Number	11426964
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the as lvp 20d low sorb had black foreign matter around the spike.The following information was provided by the initial reporter: "a pharmacy technician noticed today a black area around the spike.".
Event or Problem Description
It was reported that the as lvp 20d low sorb had black foreign matter around the spike.The following information was provided by the initial reporter: "a pharmacy technician noticed today a black area around the spike.".
Additional Manufacturer Narrative
H.6.Investigation: one sample was received for quality investigation.The customer complaint of foreign matter was verified by visual inspection.Upon inspection of the infusion set, the spike on the drip chamber had a black substance on the spike tip of the spike.A device history record review could not be performed on model 11426964 because a lot number was not provided by the customer.The root cause for the issue seen in this complaint is grease that is remaining on the drip chamber due to the manufacturing process.

• Brand Name: AS LVP 20D LOW SORB
• 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
• MDR Report Key: 11853130
• Report Number: 9616066-2021-51057
• Device Sequence Number: 4016741
• Product Code: FPA
• UDI-Device Identifier: 50885403232365
• UDI-Public: 50885403232365
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/24/2021

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: Health Professional
• Device Model Number: 11426964
• Device Catalogue Number: 11426964
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1