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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B BRAUN PENCAN SPINAL NEEDLE TRAY 1 UNIT PENCAN SPINAL TRAY

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B BRAUN PENCAN SPINAL NEEDLE TRAY 1 UNIT PENCAN SPINAL TRAY Back to Search Results
Model Number P25BK
Device Problem Environmental Compatibility Problem (2929)
Patient Problems Awareness during Anaesthesia (1707); Therapeutic Response, Decreased (2271)
Event Date 01/14/2016
Event Type  malfunction  
Event Description
Anesthesia placed a spinal and it had no effect. C-section was immediately changed from a local to general because of this. Patient reported all feeling/ no numbness. The pencan spinal needle tray was used for spinal anesthesia. Please be aware this same scenario (some with minimal pain relief) has occurred before, usually in the summer. We usually assume this happens because of heat exposure from the transport from warehouse to hospital delivery (to my knowledge the truck is not climate controlled) because we live in (b)(6) and summer heat rises well above 100f for several days/weeks in a row. However, this case happened during our winter month so i thought i would try reporting to your site instead of talking to the mfr. Who never gives me any follow-up. Your input would be greatly appreciated.
 
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Brand NamePENCAN SPINAL NEEDLE TRAY 1 UNIT
Type of DevicePENCAN SPINAL TRAY
Manufacturer (Section D)
B BRAUN
bethleham PA 18018
MDR Report Key5380095
MDR Text Key36478599
Report NumberMW5059382
Device Sequence Number1
Product Code CAZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 01/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2017
Device Model NumberP25BK
Device Catalogue Number333851
Device Lot Number61454835
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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