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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD¿ CONTINUOUS EPIDURAL TRAY: BD PERISAFE¿ NYLON EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT CATHETER

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CAREFUSION, INC BD¿ CONTINUOUS EPIDURAL TRAY: BD PERISAFE¿ NYLON EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT CATHETER Back to Search Results
Catalog Number 400831
Device Problems Loose or Intermittent Connection (1371); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. Pma/510(k)#: enforcement discretion. 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¿ continuous epidural tray: bd perisafe¿ nylon epidural catheter had loose closure at the connection with the catheter allowing the connection to separate. No serious injury or medical intervention was reported.
 
Event Description
It was reported that bd continuous epidural tray: bd perisafe nylon epidural catheter had loose closure at the connection with the catheter allowing the connection to separate. No serious injury or medical intervention was reported.
 
Manufacturer Narrative
Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. A device history review could not be completed as no batch number was provided. Investigation conclusion: no root cause can be determined as no samples were received. Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: no.
 
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Brand NameBD¿ CONTINUOUS EPIDURAL TRAY: BD PERISAFE¿ NYLON EPIDURAL CATHETER
Type of DeviceANESTHESIA CONDUCTION KIT CATHETER
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key7789920
MDR Text Key117442240
Report Number1625685-2018-00036
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
SEE H.10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 09/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number400831
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/16/2018 Patient Sequence Number: 1
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