SMITHS MEDICAL ASD, INC. JELCO SAFETY VIAVALVE CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
|
Back to Search Results |
|
Model Number 326610 |
Device Problems
Break (1069); Material Fragmentation (1261)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/10/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
One 20g viavalve catheter assembly, without sheath, needle guard assembly and blister packaging, was returned for analysis.Initial visual examination of the sample confirmed that there was no catheter tube present.Magnified examination of the sample also displayed evidence of damage to the catheter hub nose od, consistent with scissors inadvertently cutting against the hub.Additionally, visual examination of the seal component displayed no evidence of actuation.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
|
|
Event Description
|
It was reported that a when the customer removed saline lock of a smiths medical catheter no cathlon was noted on the end.Patient was examined via x-ray in effort to locate catheter piece.No piece was found and no further treatment was needed.
|
|
Manufacturer Narrative
|
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
|
|
Search Alerts/Recalls
|
|
|