|
Catalog Number 406047 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/02/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Other occupation: unit supervisor, labor & delivery/high risk ob.Pma / 510(k)#: enforcement discretion.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 the tray epid cont we18g3.5 c20 lor5 s/l/l-e had disconnected "between the epidural catheter and the yellow tubing", with the tubing "leaking rop/fent on the floor", while 30 minutes later, leakage was also discovered at the "connection piece", which was noticed to be cracked upon replacement.
|
|
Manufacturer Narrative
|
Investigation: one sample was received for evaluation.Visual evaluation confirmed the reported failure mode (damaged connector).The connector was badly cracked at the parting line.The source for the cracking could not be confirmed by the evaluation but based on the reviewed sample, the most likely contributor was identified as over-torqueing of the connector.However, the investigation was not able identify a probable root cause for the observed failure mode since all influences on the connector while in used are not known and not retrievable by this investigation.Since no probable root cause was identified at the manufacturing site or during distribution, the investigation was not able to identify any corrective or preventive actions.A review of the device history records shows that all inspection results passed per the dhr process and no anomalies were noticed during production.
|
|
Event Description
|
It was reported that the tray epid cont we18g3.5 c20 lor5 s/l/l-e had disconnected "between the epidural catheter and the yellow tubing", with the tubing "leaking rop/fent on the floor", while 30 minutes later, leakage was also discovered at the "connection piece", which was noticed to be cracked upon replacement.
|
|
Search Alerts/Recalls
|
|
|