Catalog Number 42519E |
Device Problem
Loose or Intermittent Connection (1371)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/16/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported that the bd alaris¿ smartsite¿ gravity set had a loose connection.The following information was provided by the initial reporter: " i have a few more of the 42519e iv sets that are defective.1 the connections are not tight.".
|
|
Event Description
|
It was reported that the bd alaris¿ smartsite¿ gravity set had a loose connection.The following information was provided by the initial reporter: " i have a few more of the 42519e iv sets that are defective.1 the connections are not tight.".
|
|
Manufacturer Narrative
|
H6: investigation summary: three samples were submitted for quality investigation.One of the samples was received without a drip chamber, however, the customer did not indicate that this was a failure and it could not be determined if the drip chamber separated from the assembly or if it was cut away from the assembly.The customer complaint of connection issue was not verified by investigation of the samples.The connections for each infusion set were checked to make sure they were hand tight.All connections and caps were verified hand tight.The sets were then clamped below the drip chamber location, and pressurized with air.While pressurized the set was submerged in water and checked to see if the connections remained sealed.There were no indications of bubbles coming from the assemblies and therefore the reported connection issues could not be verified.No other issues were identified on the samples.A device history record review for model 42519e lot number 22109332 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the reported connection issues could not be determined because the failure could not be replicated.
|
|
Search Alerts/Recalls
|