Catalog Number MZ5309 |
Device Problem
Loose or Intermittent Connection (1371)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/30/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
|
|
Event Description
|
Material # mz5309 lot # 23059004 it was reported by customer that j loop malfunctioned.It was pouring out normal saline as nurse was pushing it.Connections were checked and they were tightened.Verbatim: rcc received a complaint via email.Email(s) attached.J loop malfunctioned.It was pouring out normal saline as nurse was pushing it.Connections were checked and they were tightened.No harm came to patient.Product#: mz5309 lot#: 23059004.
|
|
Manufacturer Narrative
|
It was reported by customer that j loop malfunctioned.It was pouring out normal saline as nurse was pushing it.Connections were checked and they were tightened.No product or photo was returned by the customer.The customer complaint of loose component - leak could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model mz5309 lot number 23059004 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02may2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
|
|
Event Description
|
No additional information was provided.Material # mz5309 lot # 23059004 it was reported by customer that j loop malfunctioned.It was pouring out normal saline as nurse was pushing it.Connections were checked and they were tightened.Rcc received a complaint via email.Email(s) attached.J loop malfunctioned.It was pouring out normal saline as nurse was pushing it.Connections were checked and they were tightened.No harm came to patient.Product#: mz5309 lot#: 23059004.
|
|
Search Alerts/Recalls
|