BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE; BLOOD SPECIMEN COLLECTION DEVICE
|
Back to Search Results |
|
Catalog Number 364314 |
Device Problems
Leak/Splash (1354); Improper Flow or Infusion (2954)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/25/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and functional testing, each drawn with water, and no issues were observed relating to leakage / insufficient flow as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure modes leakage / insufficient blood flow.Bd was not able to identify a root cause for the indicated failure modes.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.".
|
|
Event Description
|
It was reported when using the bd preset¿ arterial blood collection syringe nurse found blood oozing from the plunger of the arterial blood collector and blood on the glove.The following information was provided by the initial reporter.The customer stated: "the nurse collected arterial blood for inpatients for blood gas analysis.After successful arterial puncture, the nurse found blood oozing from the plunger of the arterial blood collector and blood on the glove.After 0.5ml blood was collected, the arterial blood collector automatically stopped, and the automatic blood collection could not continue.The nurse had to pull the needle and take the blood again.".
|
|
Search Alerts/Recalls
|
|
|