Catalog Number 394995 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
Radiation Overdose (1510)
|
Event Date 10/29/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
|
|
Event Description
|
It was reported that while using bd connecta¿ stopcock the tubing broke.The patient had to have ct repeated, thus additional round of contrast given.Double amount of radiation also provided.The following information was provided by the initial reporter: the issue is regarding a broken tube.Course of treatment changed due to event: yes, double the amount of radiation; course of treatment changed due to event: yes, the ct process (contrast medium infusion) had to be repeated; exposure to blood/bodily fluid: no; medical int.Other than first aid: yes, possible damage to the kidney from contrast media; needle/probe stick; no; safety issue: yes, pressure problem with ct process; other actions taken: yes, more contrast media used than required.
|
|
Event Description
|
It was reported that while using bd connecta¿ stopcock the tubing broke.The patient had to have ct repeated, thus additional round of contrast given.Double amount of radiation also provided.The following information was provided by the initial reporter: the issue is regarding a broken tube.-course of treatment changed due to event: yes, double the amount of radiation; -course of treatment changed due to event: yes, the ct process (contrast medium infusion) had to be repeated; -exposure to blood/bodily fluid: no; -medical int.Other than first aid: yes, possible damage to the kidney from contrast media; -needle/probe stick; no; -safety issue: yes, pressure problem with ct process; -other actions taken: yes, more contrast media used than required.
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 1/15/2021 h.6.Investigation: a device history record review was performed for provided lot number 0115358 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, the physical sample was returned for evaluation by our quality engineer team.Through examination of the sample, the tube was observed detached from the product.Maintenance records were evaluated and no anomalies were identified that could have contributed to this defect.See h.10.
|
|
Search Alerts/Recalls
|
|