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

Catalog Number 388335

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Inflammation (1932)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd angiocath¿ autoguard¿ shielded iv catheter caused inflammation in the patient after serotherapy.No medical intervention was reported.

Event Description

It was reported that bd angiocath¿ autoguard¿ shielded iv catheter caused inflammation in the patient after serotherapy.No medical intervention was reported.

Manufacturer Narrative

Investigation summary: photos or samples are not available for analysis.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of irritation/ inflammation with lot #7360956 regarding item #388335.A review of the device history record was completed for sub-assembly #004713bjf, lot 7331984 manufactured from 30-nov-17 to 30-dec-17 at acam #3 used in lot 7360956 claimed.This lot was reviewed regarding the tests of 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.No records of quality notification or reports of non-conformity that could lead to incidents in to the lots involved in this complaint were evidenced.Investigation conclusion: without samples for analysis, it is not possible to confirm the defect of irritation/ inflammation reported in this complaint.It was not possible to verify this complaint as being generated by manufacturing process.Root cause description: based on the investigation results to date the root cause was not determinate for the defect described in this complaint.Rationale: complaints received for this device and the reported defect will continue to be tracked and trended.The information will be captured in the trend reports and monitored monthly.Collected data are regularly reviewed to identify emerging trends.Based on this, a capa is not needed at this time.

• Brand Name: BD ANGIOCATH¿ AUTOGUARD¿ SHIELDED 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: 8196716
• MDR Text Key: 131419524
• Report Number: 9610048-2018-00220
• 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
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 388335
• Device Lot Number: 7360956
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other