MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 388336

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 24g x 0.75in; catalog: 388336; lot: 3155079.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: 3114266 produced in 05/15/2013 the 05/31/2013 and the lot: 3147085 produced in 05/31/2013 the 06/27/2013 on acam machine # 1 used in the claimed final product batch: 3155079 of angiocath 24g x 0.75in 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.

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 7494882
• MDR Text Key: 107632947
• Report Number: 9610048-2018-00052
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 388336
• Device Lot Number: 3155079
• Date Manufacturer Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention