Catalog Number 200250 |
Device Problem
Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/30/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The manufacturing location for this product is gilero llc usa.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown h.4 device manufacture date: unknown b.3.Date of event: unknown.The date received by manufacturer has been used for this field.
|
|
Event Description
|
It was reported that the bd smartsite¿ bag access device experienced component separation.This is 1 of 5 events.The following information was provided by the initial reporter: 2 of our cadd patients had their tubing fall out of their 5-fu bags.The spike itself came out of the port.This is the first week we have started to really use the new style empty bag.In addition to the 2 above, one of the rn's had a "pump off" today and while removing the pump she noted how the tubing would spin.They gave me this bag so we could see it.It's inside a chemo bag on the counter.Further discussion with the nurses and they said a patient last week noticed a little leaking from their bag.At the time they didn't think much of it.Another patient was noted to have some white "residue" when they came for their pump off.(b)(6) did mention she noticed the spikes go in the bag much easier than the older style bag.So perhaps they are coming out easier too.
|
|
Event Description
|
It was reported that the bd smartsite¿ bag access device experienced component separation.This is 1 of 5 events.The following information was provided by the initial reporter: 2 of our cadd patients had their tubing fall out of their 5-fu bags.The spike itself came out of the port.This is the first week we have started to really use the new style empty bag.In addition to the 2 above, one of the rn's had a "pump off" today and while removing the pump she noted how the tubing would spin.They gave me this bag so we could see it.It's inside a chemo bag on the counter.Further discussion with the nurses and they said a patient last week noticed a little leaking from their bag.At the time they didn't think much of it.Another patient was noted to have some white "residue" when they came for their pump off.Xxxxx did mention she noticed the spikes go in the bag much easier than the older style bag.So perhaps they are coming out easier too.
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d4: medical device lot #: 00338 d4: medical device expiration date: 10-jan-2025 h4: device manufacture date: 12-may-2022 h6: investigation summary a complaint of set coming apart during use was received from the customer.No product or photo was returned by the customer.The customer complaint of separation - leak could not be verified due to the product not being returned for failure investigation.The supplier of this set was notified of the defect.Device history record results could not be obtained from the supplier.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.
|
|
Search Alerts/Recalls
|