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U.S. Department of Health and Human Services

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

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
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.
 
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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 Key8196716
MDR Text Key131419524
Report Number9610048-2018-00220
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
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 Date12/31/2022
Device Catalogue Number388335
Device Lot Number7360956
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/11/2018
Initial Date FDA Received12/26/2018
Supplement Dates Manufacturer Received12/11/2018
Supplement Dates FDA Received01/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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