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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ PERIPHERAL VENOUS CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ PERIPHERAL VENOUS CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381223
Device Problem Insufficient Information (3190)
Patient Problems Bruise/Contusion (1754); Swelling (2091); Injury (2348)
Event Date 02/22/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. (b)(4) manufacture. There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information, we are unable to determine where the device was manufactured.
 
Event Description
It was reported that after use, an unspecified bd catheter caused serious injury. On (b)(6), st an iv catheter was placed, the catheter was removed and the cat was found to have bruising and swelling. The cat was sent home but returned on (b)(6) due to the swelling to receive medical intervention. No further information is available stating what medical intervention was given.
 
Manufacturer Narrative
Additional information has been received for this complaint. The following fields have been updated: describe event or problem it was reported that after use bd insyte¿ peripheral venous catheter caused serious injury as the iv catheter was removed bruising and swelling was noticed after the catheter was removed from the cat. ¿this patient had identical swelling from the catheter site down to the toes. However the swelling started to go down after a few weeks and was fully functional. This patient was sent home but did come in to have it checked weekly to make sure swelling and redness continued to go down. The leg as of a few days ago was reported to be completely recovered as examined by one of our veterinarians. ¿ relevant tests/laboratory data -weekly visits to monitor swelling and redness. The medical device manufacturer location for this device is (b)(4). Manufacturer site no. (b)(4). Medical device brand name: bd insyte¿ peripheral venous catheter. Medical device type: foz. , medical device manufacturer: (b)(4). Common device name: intravascular catheter. Medical device catalog #: 381223, medical device lot #: 7234928, expiration date: 07/31/2022, unique identifier (udi) #: (b)(4)). Manufacturing location: (b)(4). Device manufacture date: 09/11/2017.
 
Event Description
It was reported that after use bd insyte¿ peripheral venous catheter caused serious injury as the iv catheter was removed bruising and swelling was noticed after the catheter was removed from the cat. ¿this patient had identical swelling from the catheter site down to the toes. However the swelling started to go down after a few weeks and was fully functional. This patient was sent home but did come in to have it checked weekly to make sure swelling and redness continued to go down. The leg as of a few days ago was reported to be completely recovered as examined by one of our veterinarians. ¿ relevant tests/laboratory data: weekly visits to monitor swelling and redness.
 
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Brand NameBD INSYTE¿ PERIPHERAL VENOUS CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora NJ 07417
MDR Report Key7342190
MDR Text Key102511963
Report Number2243072-2018-00141
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381223
Device Lot Number7234928
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/15/2018 Patient Sequence Number: 1
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