BARD ACCESS SYSTEMS POWERPORT ISP IMPLANTABLE PORT, GROSHONG, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Model Number CP00003 |
Device Problems
Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Perforation (2001); Swelling (2091)
|
Event Type
Injury
|
Manufacturer Narrative
|
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/ evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/ patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 12/2020).
|
|
Event Description
|
It was reported that approximately ten months post port placement, the patient allegedly had perforation in the proximal aspect of the catheter.The patient's current status was unknown.
|
|
Manufacturer Narrative
|
H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Therefore, the reported catheter fracture perforation issue cannot be confirmed.A definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: (expiry date: 12/2020).H11: section a through f - 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 approximately ten months post port placement, the patient allegedly experienced redness and swelling.Reportedly the following week, interventional radiologist performed a central venous access device (cvad) evaluation and the findings indicated there was a perforation in the proximal aspect of the catheter.The patient's current status was unknown.
|
|
Search Alerts/Recalls
|
|
|