C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Model Number 1808060 |
Device Problems
Suction Problem (2170); Blocked Connection (2888)
|
Patient Problems
Bruise/Contusion (1754); Inflammation (1932)
|
Event Date 04/16/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
As the lot number for the device was provided, a review of the device history records 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: 05/2015).Device not returned.
|
|
Event Description
|
It was reported that post port device implant, the device was allegedly unable to be aspirated.It was further reported that the device was unable to be accessed due to redness in skin and bruising.The current status of the patient is unknown.
|
|
Manufacturer Narrative
|
H10: manufacturing review: a complaint history review was performed.This is the second complaint reported for this lot number and the lot met all release criteria.A device history record review is required.Investigation summary: the device was not returned for evaluation.The investigation is inconclusive for the reported unable to aspirate, difficult to access issue.Furthermore, the clinical condition alleged is cannot be confirmed.A definitive root cause could not be determined based on the 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: d4 (expiry date: 05/2015), g3, h6(method).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 sometime post port device implant, the device was allegedly unable to be aspirated.It was further reported that the device was unable to be accessed and caused redness in skin and bruising.The current status of the patient is unknown.
|
|
Search Alerts/Recalls
|
|
|