BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ IV CATHETER; INTRAVASCULAR CATHETER
|
Back to Search Results |
|
Catalog Number 388333 |
Device Problem
Material Too Rigid or Stiff (1544)
|
Patient Problem
Phlebitis (2004)
|
Event Date 04/20/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported with the use of the bd angiocath¿ iv catheter there was issue with phlebitis.It was stated the ¿while using the material on the patient, the catheter is stiff and patients were losing the access in vein and getting lesions.Due to this, prolongation of hospitalization was necessary because of an infection called phlebitis.Ms.(b)(6) contacted, she confirmed that there was prolongation of hospitalization, but does not know about medical intervention, if there was treatment and about the patients involved.¿.
|
|
Manufacturer Narrative
|
Investigation summary: samples/ photos: one sealed and unused sample was received of the angiocath 20g x 1.16in; catalog: 388333; lot: 3136477.The sample received were submitted to penetration testing of tip of the needle, tip of the catheter and sliding of the catheter.As a result of these tests, all parameters were within the specifications for the product.Dhr/ qn/ ncmr review: the final assembly batch: 3114261 produced in 05/15/2013 the 05/31/2013 on acam machine #4 used in the claimed final product batch: 3136477 of angiocath 20g x 1.16in was analyzed for needle tip penetration, catheter tip penetration and drag catheter test, and it was not evidenced results of these tests out of specification and no other records were found that could lead to this complaint.Qn/ ncmr review: there are no quality notification (qn) or non-conformity material report records of needle through catheter for the lots involved in this complaint.Investigation conclusion: not confirmed: bd was unable to confirm or reproduce the incidents claimed.The test carried out on the sample received from the client presented a result of the parameters within the specifications for the product and according to the batch history analysis and historical analysis of nonconformities/ quality notification no records were found that could cause this claim, so it is not possible to confirm the claimed defect.
|
|
Search Alerts/Recalls
|
|
|