BARD ACCESS SYSTEMS POWERPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Model Number 1708000 |
Device Problems
Fracture (1260); Material Puncture/Hole (1504)
|
Patient Problem
Death (1802)
|
Event Type
Death
|
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.(expiration date: 07/2016).
|
|
Event Description
|
It was reported that post port device explant, after the patient was awakened from a medically induced coma, the port allegedly had a hole and was broken in half.It was further reported that the port could not be replaced, and the patient was unable to receive medication.Reportedly, the patient expired.
|
|
Event Description
|
It was reported that post port device explant, after the patient was awakened from a medically induced coma, the port allegedly had a hole and was broken in half.It was further reported that the port could not be replaced, and the patient was unable to receive medication.Reportedly, the patient expired.
|
|
Manufacturer Narrative
|
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: a sample evaluation could not be performed as the samples were not returned.Due to the lack of a returned sample the investigation cannot be confirmed for the alleged break in the port/catheter.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: d4 (expiration date: 07/2016),g4.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.
|
|
Search Alerts/Recalls
|
|
|