MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. PCA KIT ASV MICROBORE CV; INTRAVASCULAR ADMINISTRATION SET

Model Number	10800175
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that pca kit asv microbore cv leaked.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported by the customer they had two defective sets that leaked.
Additional Manufacturer Narrative
H.6.Investigation: 60 unused extension sets, model 10800175 lot 20055559, was received by the customer for investigation.10 loose unopened packages of 10800175 and one box of 50 unopened samples were returned.All sets were visual inspected for defects and functionally tested for leakage.No leaks were observed.The customer's complaint that two defective sets leaked could not be verified.A device history record review for model 10800175 lot number 20055559 was performed.The reported defect was found during the production process of this batch and a requalification was performed.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of leakage with lot #20055559 regarding item #10800175.
Event or Problem Description
It was reported that pca kit asv microbore cv leaked.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported by the customer they had two defective sets that leaked.

• Brand Name: PCA KIT ASV MICROBORE CV
• 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: 12006063
• Report Number: 9616066-2021-51320
• Device Sequence Number: 19043709
• Product Code: FPA
• UDI-Device Identifier: 50885403234406
• UDI-Public: 50885403234406
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: 05/08/2023
• Device Model Number: 10800175
• Device Catalogue Number: 10800175
• Device Lot Number: 20055559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1