Catalog Number 300865 |
Device Problems
Crack (1135); Leak/Splash (1354)
|
Patient Problem
Low Blood Pressure/ Hypotension (1914)
|
Event Date 04/15/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).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 there was a crack in barrel during administration with a bd plastipak¿ 50ml concentric luer lock syringe.The following information was provided by the initial reporter, translated from (b)(6) to english: syringe prepared and administered intravenously with pump at speed 3.During the administration (20ml remaining in the syringe) the patient fell at 30 systolic arterial tension (strong hypotension).Alerted, the hcw sees a product leakage with the current syringe.She changes it and finds a crack at the 15ml graduation.
|
|
Event Description
|
It was reported that there was a crack in barrel during administration with a bd plastipak¿ 50ml concentric luer lock syringe.The following information was provided by the initial reporter, translated from french to english: syringe prepared and administered intravenously with pump at speed 3.During the administration ( 20ml remaining in the syringe) the patient fell at 30 systolic arterial tension (strong hypotension).Alerted, the hcw sees a product leakage with the current syringe.She changes it and finds a crack at the 15ml graduation.
|
|
Manufacturer Narrative
|
Investigation: one sample was returned for investigation.Upon visually inspecting the product, damage was observed between the 15ml and 20ml marking as well as near the barrel flags, which lead to the leak reported.A device history review was performed for reported lot 1902233, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.The damage noted is consistent with the assembly wheels that guide the barrel in the machine.While we could not identify a direct issue, it was determined this instance likely occurred as a result of the product jamming within the manufacturing equipment.
|
|
Search Alerts/Recalls
|