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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORPORATION VERSASAFE SPLIT SEPTUM SET
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CAREFUSION CORPORATION VERSASAFE SPLIT SEPTUM SET Back to Search Results
Model Number 10796814
Device Problems Migration or Expulsion of Device (1395); Occlusion Within Device (1423); Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2014
Event Type  malfunction  
Event Description
The customer reported the split septum port was pushed into the tubing and occluded the set.This occurred when accessing the port with a blunt needle, while trying to administer an iv push medication.There was no patient harm or medical intervention required.No additional event or patient information is available.
 
Manufacturer Narrative
(b)(4).The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
 
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Brand Name
VERSASAFE SPLIT SEPTUM SET
Manufacturer (Section D)
CAREFUSION CORPORATION
san diego CA
Manufacturer Contact
stephen bilello
10020 pacific mesa blvd.
san diego, CA 92121
8586176477
MDR Report Key3944164
MDR Text Key4599031
Report Number9616066-2014-00445
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Biomedical Engineer
Remedial Action Other
Type of Report Initial
Report Date 04/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10796814
Device Catalogue Number10796814
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/05/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/22/2014
Initial Date FDA Received05/07/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MODEL 9391-0200, LOT UNK; VERSASAFE SPLIT SEPTUM PLASTIC CANNULA:
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