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U.S. Department of Health and Human Services

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

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38183414
Device Problem Material Rupture (1546)
Patient Problems Extravasation (1842); Tissue Damage (2104); Distress (2329); Discomfort (2330)
Event Date 02/26/2018
Event Type  Injury  
Manufacturer Narrative
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 when having to perform multiple venipunctures due to the "plastic catheter" rupturing on a bd insyte¿ autoguard¿ bc, the patient reported "discomfort, stress, altered vital signs, soft tissue trauma, and bruises on the skin" it was also reported that the patient may have permanent psychic trauma due to the repeated venous punctures. "these traumas are related to the involvement of extravascular space, directly injuring the vessel structure and triggering impacts on areas close to it due to extravasation. These traumas were treated and medicine prescribed was polysulfate of mucopolysaccharide (hirudóide) prescribed by the medicine. ".
 
Manufacturer Narrative
Investigation summary: photos or samples are not available for analysis so our quality engineer was unable to verify the reported complaint. Dhr review: as this is a reportable complaint, lot: 7335854 was analyzed and no records of data that could lead to the incident in question were evidenced. Qn/ ncmr review: there are no quality notification (qn) or non-conformity report records that lead to this condition, for the lots involved in this complaint. Because no objective evidence of this issue was found during the analysis of the device history record and quality notifications for the claimed lot, it was not possible to confirm this complaint as being generated by manufacturing process. Additional investigations found when there was difficulty in the use of the product by the customer it was not a failure arising from the manufacturing of the product. Based on the information contained in this complaint it may be determined that the root cause is related to failure by the user to use the product. 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 NameBD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
MDR Report Key7468658
MDR Text Key106746729
Report Number9610048-2018-00054
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818341
UDI-Public00382903818341
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,user facility
Type of Report Initial,Followup
Report Date 05/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2020
Device Catalogue Number38183414
Device Lot Number7335854
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/27/2018 Patient Sequence Number: 1
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