Model Number IPN046311 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
Headache, Lumbar Puncture (2186)
|
Event Date 08/17/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
|
|
Event Description
|
It was reported that the plunger is air leaking.The doctor (anesthetist) faced 2 incidents during the night of wednesday (b)(6) 2020.With 2 different lot numbers.Lot#:71f20e0804 and 71f20e0956.There was no consequence for the two female patients but a risk.During the week 35 ((b)(6) 2020),another doctor(anesthetist) faced 2 incidents with lot# 71f20e0804 and 71f20e095.The consequences for the 2 female patients were: dura mater breaches so a blood patch had to be applied for each.
|
|
Event Description
|
It was reported that the plunger is air leaking.The doctor(anesthetist)faced 2 incidents during the night of wednesday 25 to 26 of (b)(6).With 2 different lot numbers.Lot#:71f20e0804 and 71f20e0956.There was no consequence for the two female patients but a risk.During the week 35 (17 to 23 aug 20),another doctor(anesthetist) faced 2 incidents with lot# 71f20e0804 and 71f20e095.The consequences for the 2 female patients were: dura mater breaches so a blood patch had to be applied for each.
|
|
Manufacturer Narrative
|
(b)(4).A device history record review was performed on the lor syringe with no relevant findings.A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.Per eco-057562 (released 12-mar-2020), supplier (preox) made the following changes: optional component materials/mold locations: option 1: barrel: polypropylene - profax pf-535 lyondell-basell plunger: polypropylene 100-ga12 ineos olefins & polymers (molded at fleima plastic) blue stopper: silicone rubber (molded at et elastomer technik) option 2: barrel: polypropylene - profax pf-535 lyondell-basell, plunger: polypropylene profax pf-531 lyondell-basell (molded at gpe), blue stopper: silicone rubber (molded at psilkon).Lubricant: - the i.D.Of the barrel lubricated w/ medical grade silicone (polydimethylsiloxan) and amount will not exceed 0.25mg per sq centimeter.These effective changes did impact product design and material.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.
|
|
Search Alerts/Recalls
|