Model Number 382533 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/04/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It was reported that bd insyte autog bc pnk 20ga x 1.0in had foreign matter.The following information was provided by the initial reporter: the catheter failed.Verbatim: lab has identified another failed 20g iv catheter.Debris was noted on the tip.The catheter was not inserted.
|
|
Manufacturer Narrative
|
The following fields have been updated with additional information: d.4.Medical device lot #: 1144503.D.4.Medical device expiration date: 2024-05-31.H.4.Device manufacture date: 2021-05-24.
|
|
Event Description
|
It was reported that bd insyte autog bc pnk 20ga x 1.0in had foreign matter.The following information was provided by the initial reporter: the catheter failed.Verbatim: lab has identified another failed 20g iv catheter.Debris was noted on the tip.The catheter was not inserted.
|
|
Event Description
|
It was reported that bd insyte autog bc pnk 20ga x 1.0in had foreign matter.The following information was provided by the initial reporter: the catheter failed.Verbatim: lab has identified another failed 20g iv catheter.Debris was noted on the tip.The catheter was not inserted.
|
|
Manufacturer Narrative
|
H.6.Investigation: our quality engineer inspected the samples submitted for evaluation.Bd received three units, two were within opened unit packages and one was without packaging.Visual and microscopic observation of the returned units revealed there was no evidence of foreign material anywhere on the units.It was observed that lubrication could be seen on the tip; however, this material is considered non-foreign and the amount of lubrication was determined to be within specification.As the returned units were found to be within specification, bd was unable to confirm the reported defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
|
|
Search Alerts/Recalls
|