Catalog Number 400713 |
Device Problems
Break (1069); Leak/Splash (1354); Packaging Problem (3007)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/08/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Initial reporter phone #: unknown.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 during use it was discovered the epidural catheter was damaged with a bd anesthesia kit durasafe¿.The following information was provided by the initial reporter, translated from portuguese to english: when introducing the epidural catheter, he realizes that it is torn and for safety he decides to remove it, since it is inserted blindly.
|
|
Manufacturer Narrative
|
The following fields have been updated with additional information: b.5.Describe event or problem: it was reported that during use it was discovered the epidural catheter was damaged with a bd anesthesia kit durasafe¿.The following information was provided by the initial reporter, translated from portuguese to english: when introducing the epidural catheter, he realizes that it is torn and for safety he decides to remove it, since it is inserted blindly.Additionally the customer provided the following additional information: the packaging of the material and therefore, as there is no certainty of the integrity of the product.We proceeded to return it to the central pharmacy and not use it on the patient.Another material was used.No damage.F.10 device codes: 3007.
|
|
Event Description
|
It was reported that during use it was discovered the epidural catheter was damaged with a bd anesthesia kit durasafe¿.The following information was provided by the initial reporter, translated from portuguese to english: when introducing the epidural catheter, he realizes that it is torn and for safety he decides to remove it, since it is inserted blindly.Additionally the customer provided the following additional information: the packaging of the material and therefore, as there is no certainty of the integrity of the product.We proceeded to return it to the central pharmacy and not use it on the patient.Another material was used.No damage.
|
|
Event Description
|
It was reported that during use it was discovered the epidural catheter was damaged with a bd anesthesia kit durasafe¿.The following information was provided by the initial reporter, translated from portuguese to english: when introducing the epidural catheter, he realizes that it is torn and for safety he decides to remove it, since it is inserted blindly.Additionally the customer provided the following additional information: the packaging of the material and therefore, as there is no certainty of the integrity of the product.We proceeded to return it to the central pharmacy and not use it on the patient.Another material was used.No damage.
|
|
Manufacturer Narrative
|
H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 9091868.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Bd was not able to confirm the customer¿s indicated failure mode.
|
|
Search Alerts/Recalls
|