Model Number 415122 |
Device Problem
Physical Resistance/Sticking (4012)
|
Patient Problems
Bacterial Infection (1735); Fever (1858)
|
Event Date 07/17/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
|
|
Event Description
|
As reported by the user facility: it was reported that several patients with the caresite connected to them have been running a fever.When blood culture was performed, resident skin bacteria was detected.It is suspected that those bacteria may have been mixed-in from the "shrunk valve".
|
|
Manufacturer Narrative
|
This report has been identified as b.Braun medical internal report number(b)(4).Six (6) photographs were provided for evaluation.In addition a total of 11 used samples were also provided.Visual examination of the photographs noted that the piston was stuck in the depressed position.Two of the eleven samples were noted to still be in the depressed position.The two samples that were stuck in the depressed position were exercised with a luer lock syringe and returned to an undepressed state.All samples were dissected to observe the silicone piston and it was noted that 4 of the pistons had a tear at the base of the piston slit.The dimensions for the piston were evaluated per internal specification and found to be acceptable.House retain samples were tested per internal specification and found acceptable.In addition the samples were accessed multiple times and dissected in order to evaluate the silicone piston.The silicone piston was found acceptable with no damage noted.In addition 4 sets of retain samples that contained the same piston lots were evaluated and found to be within specification.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
|
|
Search Alerts/Recalls
|