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

Model Number	30873
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a crack was found in the pca asv microbore cv tubing sets distal end during use.The following information was provided by the initial reporter: "our nursing teams have came across a tubing set that has cracked while on a patient.From the feedback i¿ve heard the crack occurs at the connector on the distal end and was noticed more than once.".
Event or Problem Description
It was reported that a crack was found in the pca asv microbore cv tubing sets distal end during use.The following information was provided by the initial reporter: "our nursing teams have came across a tubing set that has cracked while on a patient.From the feedback i¿ve heard the crack occurs at the connector on the distal end and was noticed more than once.".
Additional Manufacturer Narrative
H6: investigation summary: a complaint of a cracked female luer was received from the customer.One sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.A crack was found on the outside of the female luer.A device history record review for model 30873 lot number 20096127 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10sep2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause was identified as internal stresses created in the luer during manufacturing process that makes it more susceptible to chemical/mechanical attacks.

• Brand Name: PCA 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: 11529953
• Report Number: 9616066-2021-50513
• Device Sequence Number: 14744996
• Product Code: FPA
• UDI-Device Identifier: 50885403273948
• UDI-Public: 50885403273948
• 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,Followup
• Report Date (Section B): 03/24/2021

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 Expiration Date: 09/10/2023
• Device Model Number: 30873
• Device Catalogue Number: 30873
• Device Lot Number: 20096127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1