Catalog Number UNKNOWN |
Device Problem
Complete Blockage (1094)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/24/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Medical device expiration date: unknown.A device manufacture date: unknown.Device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
|
|
Event Description
|
It was reported that an unspecified bd infusion set had flow issues.The following information was provided by the initial reporter: "it was reported that a 50ml bag of iv bumex drip started at 2320 running at 4ml/hr.Rn noticed upon assessment that bag had almost run dry at 0430.".
|
|
Event Description
|
It was reported that an unspecified bd infusion set had flow issues.The following information was provided by the initial reporter: "it was reported that a 50ml bag of iv bumex drip started at 2320 running at 4ml/hr.Rn noticed upon assessment that bag had almost run dry at 0430.".
|
|
Manufacturer Narrative
|
Investigation summary: no product or photo was returned by the customer.The customer complaint that a 50ml bag of iv bumex drip started at 2320 running at 4ml/hr.Rn noticed upon assessment that bag had almost run dry at 0430 could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model and lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
|
|
Search Alerts/Recalls
|