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	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown.The patients age was used to determine a placeholder date for this field.The initial reporter also notified the fda via medwatch# (b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint of leaking on the site after the connection of the syringe and tubing could not be verified due to the product not being returned for failure investigation.A device history record review for model 10800175 lot number 20116435 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 18nov2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the pca kit asv microbore cv tubing leaked after connecting it to the syringe.The following information was provided by the initial reporter: patient controlled analgesia (pca) tubing noted to be leaking on the site after the connection of the syringe and tubing.Patient s/p mva (status post motor vehicle accident) receiving dilaudid pca, for pain management to treat the pain from the left fractured femur and left arm, noted liquid dripping from the pca tubing.Set up changed to new settings.Nursing provided defective tubing.Removed tubing from operation and primed new set for patient use appropriately.This product was removed/disposed.There was no harm detected.

• 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: 12111917
• Report Number: 9616066-2021-51447
• Device Sequence Number: 19846676
• Product Code: FPA
• UDI-Device Identifier: 50885403234406
• UDI-Public: 50885403234406
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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 Expiration Date: 11/18/2023
• Device Model Number: 10800175
• Device Catalogue Number: 10800175
• Device Lot Number: 20116435
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR