MAUDE Adverse Event Report: PCA ASV MICROBORE CV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	30873
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
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 asv microbore cv had a hole in the tubing.The following information was provided by the initial reporter: it was reported by the medical professional, there was a hole in the tubing.
Event or Problem Description
It was reported that pca asv microbore cv had a hole in the tubing.The following information was provided by the initial reporter: it was reported by the medical professional, there was a hole in the tubing.
Additional Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.The customer complaint of damage component leak could not be verified due to the product not being returned for failure investigation.A device history record review for model 30873 lot number 19016360 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29jan2019.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 being 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.

• Brand Name: PCA ASV MICROBORE CV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12328582
• Report Number: 9616066-2021-51786
• Device Sequence Number: 4507829
• Product Code: FPA
• UDI-Device Identifier: 10885403273940
• UDI-Public: 10885403273940
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 01/29/2022
• Device Catalogue Number: 30873
• Device Lot Number: 19016360
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1