SMITHS MEDICAL ASD, INC. JELCO SAFETY PROTECT IV PLUS CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
|
Back to Search Results |
|
Model Number 306701 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/07/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Other text: e4: initial reporter also sent report to fda is unknown.No information has been provided to date.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
|
|
Event Description
|
It was reported that the plastic bent on the end after the needle was retracted.No patient injury was reported.
|
|
Search Alerts/Recalls
|
|
|