Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problem
Tissue Damage (2104)
|
Event Type
Injury
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
|
|
Event Description
|
It was reported that the catheter tore the patient's skin.Additional information has been requested but not yet received.
|
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
|
|
Event Description
|
It was reported that the catheter tore the patient's skin.Additional information has been requested but not yet received.
|
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
|
|
Event Description
|
It was reported that the catheter tore the patient's skin.Additional information has been requested but not yet received.
|
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
|
|
Event Description
|
It was reported that the catheter tore the patient's skin.
|
|
Manufacturer Narrative
|
The device was not returned for evaluation.The product and lot number are unknown; therefore, the device history record and labeling could not be reviewed.(b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
|
|
Event Description
|
It was reported that the catheter tore the patient's skin.
|
|
Search Alerts/Recalls
|