Device Problems
Disconnection (1171); Material Separation (1562)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd 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 bd.
|
|
Event Description
|
It was reported that the statlock device failed after two days of use when the plastic clamp separated from the adhesive backing.No medical intervention was reported.
|
|
Event Description
|
It was reported that the stalock device failed after two days of use, due to the plastic clamp separating from the adhesive backing.No medical intervention was reported.
|
|
Manufacturer Narrative
|
The reported event was confirmed.Visual evaluation noted 1 used foley statlock with no original packaging.The swivel base was detached from the adhesive pad.The lot number is unknown therefore the device history record could not be reviewed.The product family for this foley statlock product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the foley statlock product ifus are found to be adequate based on past reviews.
|
|
Search Alerts/Recalls
|