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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC SPINAL ANESTHESIA TRAY PENCAN® 25 GAUGE 3.5 INCH L; ANESTHESIA CONDUCTION KIT
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CAREFUSION, INC SPINAL ANESTHESIA TRAY PENCAN® 25 GAUGE 3.5 INCH L; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405672
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2018
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that during use of the spinal anesthesia tray pencan® 25 gauge 3.5 inch l the "bupivacaine was ineffective." it was also reported that ¿some delays in the procedure¿ happened as a result.
 
Event Description
It was reported that during use of the spinal anesthesia tray pencan® 25 gauge 3.5 inch l the "bupivacaine was ineffective." it was also reported that ¿some delays in the procedure¿ happened as a result.
 
Manufacturer Narrative
Date received by manufacturer: 2018-11-27.Awareness date has been updated from (b)(6) 2018.This was discovered during closure activities.
 
Event Description
It was reported that during use of the spinal anesthesia tray pencan® 25 gauge 3.5 inch l the "bupivacaine was ineffective." it was also reported that ¿some delays in the procedure¿ happened as a result.There were four occurrences reported from this lot number but the date/time and or patient information is unknown.
 
Manufacturer Narrative
Correction: describe event or problem: it was reported that during use of the spinal anesthesia tray pencan® 25 gauge 3.5 inch l the "bupivacaine was ineffective." it was also reported that ¿some delays in the procedure¿ happened as a result.There were four occurrences reported from this lot number but the date/time and or patient information is unknown.Investigation summary: zero photos or samples were received in the columbus plant for evaluation therefore failure mode could not be verified and root cause could not be determined.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of anesthesia ineffective with lot #1263336 regarding item #405672.A device history record review of all applicable manufacturing records for lot 0001263336 did not identify any issues that may have contributed to the reported failure mode.Investigation conclusion: over a period of more than 10 years, no test result from samples returned due to ineffective anesthesia has ever failed to meet specifications.The causes of ineffective anesthesia have been well documented in clinical literature for many years.Whereas a strong history of testing has supported that drug potency is not the cause, the actual cause may not always be ascertained.Bd has a long history of test results to support that drug potency issues have not been the cause of ineffective anesthesia events reported to bd through the complaint system.Root cause description: based on the complaint investigation, a probable root cause could not be identified for the reported failure mode.Rationale: as a preventive action, the vendor of the applicable drug component (hospira / pfizer) will be notified of the reported failure mode from the customer.Likewise, the complaint will be entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis (qda) process if an adverse trend is identified.
 
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Brand Name
SPINAL ANESTHESIA TRAY PENCAN® 25 GAUGE 3.5 INCH L
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key8185839
MDR Text Key131137337
Report Number1625685-2018-00065
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904056728
UDI-Public00382904056728
Combination Product (y/n)N
PMA/PMN Number
D219092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup,Followup
Report Date 01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2020
Device Catalogue Number405672
Device Lot Number0001263336
Date Manufacturer Received11/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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