C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 5608062 |
Device Problems
Device Damaged Prior to Use (2284); Material Integrity Problem (2978); Packaging Problem (3007)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/15/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 06/2025).H11: section a through f ¿ the information provided 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.
|
|
Event Description
|
It was reported that during the preparation of a port placement procedure, the port allegedly damaged in the packaging, sterility compromised and the product was unusable.The procedure was completed using another device.There was no patient contact.
|
|
Event Description
|
It was reported that during preparation of a port placement procedure, the tab on the outer package was allegedly damaged upon opening the inner package.It was further reported that the port allegedly damaged in the packaging, sterility compromised and the product was unusable.The procedure was completed using another device.There was no patient contact.
|
|
Manufacturer Narrative
|
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one sealed powerport implantable port kit was returned for evaluation.Gross visual evaluation was performed.The outer packaging appeared to be sealed with no damages.The port within the package was noted to be intact and no anomalies were noted.The port did not move from place within the package.Also one photo was provided for review.The photo shows two sealed powerport kit and the corners of the outer tyvek label were noted to be partially detached.However no damage was noted to inner package.Therefore the investigation is unconfirmed for the reported port damage, device damaged prior to use and packaging problem issue.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiration date: 06/2025), g3.H11: h6 (method, result, conclusion).H11: section a through f ¿ the information provided 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 : see h10.
|
|
Search Alerts/Recalls
|
|
|