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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL, INC., PORTEX SPINAL ACCESSORY PACK; ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL, INC., PORTEX SPINAL ACCESSORY PACK; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 934/000/0007
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device is returned and evaluated, the manufacturer will file a follow-up report detailing the results.
 
Event Description
A report was received explaining that the needle detached from the syringe when it was introduced to a patient.No patient or clinical adverse events were reported.
 
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Brand Name
PORTEX SPINAL ACCESSORY PACK
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL, INC.,
10 bowman drive
keene NH 03431
Manufacturer (Section G)
SMITHS MEDICAL, INC.,
10 bowman drive
keene NH 03431
Manufacturer Contact
michele seliga
1265 grey fox rd
st. paul, MN 55112
6516287604
MDR Report Key5042784
MDR Text Key24621583
Report Number2183502-2015-00622
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other
Report Date 08/31/2015
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 Expiration Date04/30/2020
Device Catalogue Number934/000/0007
Device Lot Number2933739
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/31/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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