Model Number 2202-0007 |
Device Problems
Crack (1135); Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/25/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device expiration date: unknown.Device manufacture date: unknown.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 pump module infusion set tubing was defective.The following information was provided by the initial reporter: it was reported by the customer that there was cracking in the iv tube resulting in leakage.
|
|
Manufacturer Narrative
|
Investigation summary: no product or photo was returned by the customer.The customer complaint of tubing defective / damaged could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
|
|
Event Description
|
It was reported that the bd alaris pump module infusion set tubing was defective.The following information was provided by the initial reporter: it was reported by the customer that there was cracking in the iv tube resulting in leakage.
|
|
Search Alerts/Recalls
|