BECTON, DICKINSON AND COMPANY (BD) TUBE PMS PLH 13X75 3.0 PLBL LIM CE; BLOOD SPECIMEN COLLECTION DEVICE
|
Back to Search Results |
|
Catalog Number 365050 |
Device Problem
Incorrect Measurement (1383)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/25/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used for this field.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 tube pms plh 13x75 3.0 plbl lim ce, the device experienced clogged/blocked instrumentation probe.The following information was provided by the initial reporter.The customer stated: 2-suction problem on the machine: needle clogging, partial or total, including on tubes filled up to the gauge line.These problems occur regularly, requiring washing, changing needles in the worst case, ironing checks and patients to be sure of our results.Error code: 905-030906 "vertical mvt of the sample pipette" -> blocking fault tube not always put in error on the first sample.He can do 7-8 tests and not the rest.Tube used for biochemistry and immuno.Following errors, carrying out manual and automatic interior and exterior washing.
|
|
Manufacturer Narrative
|
H.6.Investigation: bd had not received samples or photos for this evaluation therefore, retention samples from the bd inventory were selected for evaluation.Functional testing was conducted on retention samples from the bd inventory of material #365050, lot(s)# 0245299, 0311961 and 1004602 3.0ml barricror tubes and samples from material #365057, lot# 0311964 5.5ml barricor tubes.Testing was done with blood drawn from subjects and, each tube was run three times on the system with no instrument error codes being observed.Additionally, no difficulties were encountered during blood collection as all tubes appeared to exhibit proper fill and, underfill was not observed in any samples testing.Bd was unable to duplicate or confirm the customer¿s indicated failure of clogged instrumentation (aspiration alarm/ sampling errors) because the alleged defects were not evident in the testing of the bd inventory sample lot samples.All visual observations of both retain and control samples tested demonstrated clinically acceptable performance.Multiple assays performed on cobas instrumentation produced no alarms/error codes.Analytical replicates of both retain and control samples tested were acceptable in terms of both precision and accuracy.The tubes performed as expected therefore, this complaint is unconfirmed for clogged instrumentation (aspiration/ sampling error).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.
|
|
Event Description
|
It was reported when using the tube pms plh 13x75 3.0 plbl lim ce, the device experienced clogged/blocked instrumentation probe.The following information was provided by the initial reporter.The customer stated: 2-suction problem on the machine: needle clogging, partial or total, including on tubes filled up to the gauge line.These problems occur regularly, requiring washing, changing needles in the worst case, ironing checks and patients to be sure of our results.Error code: 905-030906 "vertical mvt of the sample pipette" -> blocking fault tube not always put in error on the first sample.He can do 7-8 tests and not the rest tube used for biochemistry and immuno following errors, carrying out manual and automatic interior and exterior washing.
|
|
Search Alerts/Recalls
|
|
|