Catalog Number 381023 |
Device Problems
Break (1069); Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/16/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 when using the bd insyte¿ autoguard¿ bc shielded iv catheter, the device experienced leakage from the hub.The following information was provided by the initial reporter.The customer stated: according to the customer's report, during blood collection, blood leakage from either the catheter or the side of the catheter hub occurred.
|
|
Event Description
|
It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter, the device experienced leakage from the hub due to a crack /break in the hub.The following information was provided by the initial reporter.The customer stated: according to the customer's report, during blood collection, blood leakage from either the catheter or the side of the catheter hub occurred.
|
|
Manufacturer Narrative
|
B.5.Describe event or event it was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter, the device experienced leakage from the hub due to a crack /break in the hub.The following information was provided by the initial reporter.The customer stated: according to the customer's report, during blood collection, blood leakage from either the catheter or the side of the catheter hub occurred.Annex a grid: a0504.H.6.Investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received six photographs which displayed views of a used 22ga bd insyte autoguard blood control iv catheter adapter with traces of media present and damage on the side of the adapter.Another photograph displays a view of the mold cavity number embossed on the luer adapter (9p).In addition, one used 22ga bd iag bc iv catheter adapter that is in similar condition to that as seen in the provided photos.Through the visual/microscopic observation of the catheter adapter assembly reveal that there is a hole in the adapter.The sides of the hole / opening have smooth surfaces indicating that it most likely resulted from the molding process.The missing material as observed, is most likely a result of a short shot during the molding process.A water/air leak test was performed, at which time leakage was observed at the hole in the adapter.Therefore, the defect of leakage is confirmed.During molding manufacturing, operators perform inspection for short shot per the molding sampling plan.Preventative maintenance is performed to ensure proper functioning of equipment per the quality plan.Additionally, catheter adapters are inspected for cracks or damage and leakage per the quality control and sampling plans.A device history record review showed no non-conformances associated with this issue during the production of this batch.
|
|
Search Alerts/Recalls
|
|