Catalog Number 300844 |
Device Problems
Partial Blockage (1065); Material Separation (1562); Air/Gas in Device (4062)
|
Patient Problem
Discomfort (2330)
|
Event Date 07/24/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the bd discardit¿ ii syringe had issues with air bubbles entering it while reconstituting the medication, as well as the needle being blocked and pulling out of the hub during the injection.The following information was provided by the initial reporter: "while using the discardit, staffs find difficulty to aspirate the blood and medications, finding bubbles in the syringe and needle coming out of the syringe while reconstituting the medication.Also difficult to give im injections with discardit.The syringe is getting stuck while injecting medication.
|
|
Manufacturer Narrative
|
The manufacturing location for this product is bawal, india.This site is not registered with the fda.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.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 bd discardit¿ ii syringe had issues with air bubbles entering it while reconstituting the medication, as well as the needle being blocked and pulling out of the hub during the injection.The following information was provided by the initial reporter: "while using the discardit, staffs find difficulty to aspirate the blood and medications, finding bubbles in the syringe and needle coming out of the syringe while reconstituting the medication.Also difficult to give im injections with discardit.The syringe is getting stuck while injecting medication.
|
|
Manufacturer Narrative
|
H6: investigation summary no sample (including photos) was received for evaluation of discardit ii 2ml with 24x1 from lot number 3055269 regarding material number 300844 with the reported issue of aspirate / draw (cannot / difficult), bubbles / voids in molded part, needle pulled out of hub, plunger movement difficult.The device history review was completed for material number 300844 with lot number 3055269 and there was no quality notification found from its production date to end of dispatch date.The investigation and simulation were carried out on retention samples where the investigating team has use one sample for plunger movement difficult & results found with in limit.The investigating team has visually checked the samples for bubbles / voids in molded part, needle pulled out of hub and no defect was found in the retention samples.The exact root cause can only be determined if we receive the original sample.See h10.
|
|
Search Alerts/Recalls
|