C.R. BARD, INC. (BASD) -3006260740 TITANIUM IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 0602230CE |
Device Problems
Fracture (1260); Material Separation (1562); Device Dislodged or Dislocated (2923)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/22/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that sometimes post a port placement, the safestep needle had allegedly got pulled out of the port in middle of the medication administration.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium implantable port, hickman single-lumen, 9.6f that are cleared in the us.The pro code and 510 k number for the titanium implantable port, hickman single-lumen, 9.6f are 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 return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2025).H11: section a through f ¿ the information provide by bd represents all 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.H3 other text : device pending return.
|
|
Search Alerts/Recalls
|
|
|