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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD CARIBE LTD. BD PERISAFE¿ EPIDURAL MINI-KIT EPIDURAL KIT

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BD CARIBE LTD. BD PERISAFE¿ EPIDURAL MINI-KIT EPIDURAL KIT Back to Search Results
Catalog Number 400273
Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/20/2018
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 during use of the bd perisafe¿ epidural mini-kit ¿when the product was introduced to the patient it was with difficulty, pressure is felt. When it was removed a piece of the catheter was missing. Tac is performed, but the tip of this was not found. The patient is stable, the family was notified of what happened and will be kept under observation. ¿.
 
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Brand NameBD PERISAFE¿ EPIDURAL MINI-KIT
Type of DeviceEPIDURAL KIT
Manufacturer (Section D)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
Manufacturer (Section G)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7375394
MDR Text Key103650450
Report Number2618282-2018-00009
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904002732
UDI-Public00382904002732
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K953790
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2021
Device Catalogue Number400273
Device Lot Number6197591
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/27/2018 Patient Sequence Number: 1
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