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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE 18GA X 1.16IN; INTRAVASCULAR CATHETER
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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE 18GA X 1.16IN; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38831214
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 that the insyte 18ga x 1.16in catheter separated from the hub during use and entered and "lodged" into the patient's lung.Intervention was required to remove the broken cannula from the vein, where it was initially thought to be, before it was discovered to have entered into the lung.The following information was provided by the initial reporter, translated from spanish to english: "the catheter separated from the hub and got inside patient's vein.The patient had to have intervention in order to remove the cannula inside the vein." "the catheter was not extracted from the patient's vein, once it is lodged / locked in the lung.".
 
Manufacturer Narrative
H.6.Investigation summary: a sample was not returned for investigation, but photos were received.Based on the analysis of the photos, it was concluded that the catheter cut characteristic is caused by cutting material such as scissors or stiletto during catheter removal from the patient's vein.There is no force caused on the catheter during venipuncture that can lead to a separation of the catheter body during normal insertion.In addition, it was possible to observe the presence of a catheter part inserted in the adapter, which proves that the catheter was properly fitted during the assembly of the claimed lot.A review of the device history record was performed for the reported lot, 8255854, and no quality issues were found during production.Conclusion(s): not confirmed: bd was unable to confirm the complaint for the defect claimed.Based on the analysis of the photo the vialon was embedded in the adapter, according to characteristic it can be inferred that there was a cut of the catheter during removal and the potential cause of such claim is related to failure to use the user's product.
 
Event Description
It was reported that the insyte 18ga x 1.16in catheter separated from the hub during use and entered and "lodged" into the patient's lung.Intervention was required to remove the broken cannula from the vein, where it was initially thought to be, before it was discovered to have entered into the lung.The following information was provided by the initial reporter, translated from spanish to english: "the catheter separated from the hub and got inside patient's vein.The patient had to have intervention in order to remove the cannula inside the vein." "the catheter was not extracted from the patient's vein, once it is lodged / locked in the lung.".
 
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Brand Name
INSYTE 18GA X 1.16IN
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 Key9496397
MDR Text Key186601333
Report Number9610048-2019-00352
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,user facility
Type of Report Initial,Followup
Report Date 01/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2023
Device Catalogue Number38831214
Device Lot Number8255854
Was Device Available for Evaluation? No
Date Manufacturer Received12/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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