Catalog Number UNKNOWN |
Device Problem
Leak/Splash (1354)
|
Patient Problem
Eye Injury (1845)
|
Event Date 12/05/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
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.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
|
|
Event Description
|
It was reported that during use of the unspecified bd syringe a piece of plastic from the conus of syringe fired and hit nurse¿s eye.It injured eye cornea of nurse and he is on sick leave.The following information was provided by the initial reporter: it was reported that bd discardit syringe injured hcp (nurse).A piece of plastic from the conus of syringe fired and hit nurse¿s eye.It injured eye cornea of nurse and he is on sick leave.
|
|
Manufacturer Narrative
|
H.6 investigation summary: bd was not provided with photos or samples for the investigation for this record.Unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.The material used to manufacture discardit syringes has been selected and tested to resist normal conditions of use.The assembling machines have an on-line detection system that inspects 100% the syringes, rejecting automatically the syringes with broken parts like the tip of the barrel.Bd believes that the piece of the tip could break because of the strong conditions during the use of the product.Considering our in-coming and in-process inspection, no corrective actions are required at this time.A device history record could not be completed as no lot number was provided.H3 other text : see h.10.
|
|
Event Description
|
It was reported that during use of the unspecified bd syringe a piece of plastic from the conus of syringe fired and hit nurse¿s eye.It injured eye cornea of nurse and he is on sick leave.The following information was provided by the initial reporter: it was reported that bd discardit syringe injured hcp (nurse).A piece of plastic from the conus of syringe fired and hit nurse¿s eye.It injured eye cornea of nurse and he is on sick leave.
|
|
Search Alerts/Recalls
|