C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 1716070J |
Device Problems
Nonstandard Device (1420); Defective Component (2292)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/09/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the powerport slim implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510k number for the powerport slim implantable port, chronoflex single-lumen, kit, 6f products is identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 12/2023).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 prior to port placement procedure, the gray sheath of the sheath introducer was allegedly soaking wet and could not be used.The amount of silicone oil applied may have been too much.There was no patient contact.
|
|
Manufacturer Narrative
|
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiry date: 12/2023).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 prior to port placement procedure, the gray sheath of the sheath introducer was allegedly soaking wet and could not be used.The amount of silicone oil applied may have been too much.There was no patient contact.
|
|
Search Alerts/Recalls
|
|
|