Catalog Number 388314 |
Device Problem
Break (1069)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 01/17/2022 |
Event Type
Injury
|
Event Description
|
It was reported that the bd insyte¿ iv catheter needle broke off, and medical intervention was required.No further information was provided.The following information was provided by the initial reporter, translated from (b)(6) : "it ruptured.The needle is separated from the catheter.Consequence: medical intervention".
|
|
Manufacturer Narrative
|
Age or date of birth: date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Manufacturer Narrative
|
H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h.10.
|
|
Event Description
|
It was reported that the bd insyte¿ iv catheter needle broke off, and medical intervention was required.No further information was provided.The following information was provided by the initial reporter, translated from spanish: "it ruptured.The needle is separated from the catheter.Consequence: medical intervention".
|
|
Search Alerts/Recalls
|