Catalog Number 381411 |
Device Problem
Material Perforation (2205)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/11/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
H3.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 insyte autoguard-n straight, 24g x 0.56" needle through catheter.The following information was provided by the initial reporter: when sticking patient for an iv i felt a lot of resistance and a white bulge appeared under patient's skin.I thought maybe the catheter had sheared upon insertion and directly withdrew and found that to be the case (the needle instead of passing through the end exit hole punctured through the side of the catheter making a flap in the catheter that remained attached to the catheter--didn't break off).
|
|
Event Description
|
It was reported that the bd insyte autoguard-n straight, 24g x 0.56" needle through catheter.The following information was provided by the initial reporter: when sticking patient for an iv i felt a lot of resistance and a white bulge appeared under patient's skin.I thought maybe the catheter had sheared upon insertion and directly withdrew and found that to be the case (the needle instead of passing through the end exit hole punctured through the side of the catheter making a flap in the catheter that remained attached to the catheter--didn't break off).
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 26-jul-2023.H6: investigation summary: our quality engineer inspected the sample and photograph submitted for evaluation.Bd received one unsealed 24ga x 0.56in.Insyte-n autoguard unit from lot number 3045830.Additionally, one photo was provided.Visual inspection discovered that no needle was provided for investigation.Only the catheter, packaging, and needle cover were provided.A leak test was performed where a leak on the catheter tubing was discovered.Microscopic analysis confirmed the cut on the catheter tubing resembled a needle spear through.The reported issue was confirmed.As the needle was not provided for investigation, a root cause could not be determined regarding if this defect occurred during manufacturing or during use.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
|
|
Search Alerts/Recalls
|