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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNSPECIFIED BD¿ SPINAL TRAY; ANESTHESIA KIT
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UNSPECIFIED BD¿ SPINAL TRAY; ANESTHESIA KIT Back to Search Results
Catalog Number UNKNOWN
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 11/06/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: (b)(4).Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that unspecified bd¿ spinal tray failed.The following information was provided by the initial reporter: material no.Unknown, batch no.Unknown.It is reported customer experienced 2 occasions of failed spinals.Verbiage received, - "after having no problems with the bupi from the kit.I've had 2 failed spinals in a row.One was a cerclage and one is a section.The h2 numbers are h20502733 and h20501524.Both vials of bupi were from the same batch #960803a, exp.12/21.I'll be using the bupi from the pyxis now.".
 
Manufacturer Narrative
H6: investigation summary: per an inspection of the retain samples for this vendor lot, the color and overall appearance are acceptable for drug part #8301694 based on the complaint investigation, the failure mode could not be confirmed and as a result a probable root cause could not be identified.Since no probable root cause was identified for this failure mode, the investigation was not able to identify any actions for this complaint.A device history review could not be completed as no batch number was provided.
 
Event Description
It was reported that unspecified bd¿ spinal tray failed.The following information was provided by the initial reporter: material no.Unknown, batch no.Unknown.It is reported customer experienced 2 occasions of failed spinals.Verbiage received, - "after having no problems with the bupi from the kit.I've had 2 failed spinals in a row.One was a cerclage and one is a section.The h2 numbers are h20502733 and h20501524.Both vials of bupi were from the same batch #960803a, exp.12/2021.I'll be using the bupi from the pyxis now.".
 
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Brand Name
UNSPECIFIED BD¿ SPINAL TRAY
Type of Device
ANESTHESIA KIT
MDR Report Key10939290
MDR Text Key221293344
Report Number2243072-2020-01984
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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