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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE; ANESTHESIA CONDUCTION KIT
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TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE; ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405671
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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
Material no: 405671, batch no: 0001302639.It was reported that during use of the tray spn whit25g3.5 l/b-d/e plast drape the trays have bad bupivacaine in them.This occurred on 25 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: we have about 25 spinal trays that we believe have bad bupivacaine in them.
 
Event Description
Material no: 405671, batch no: 0001302639.It was reported that during use of the tray spn whit25g3.5 l/b-d/e plast drape the trays have bad bupivacaine in them.This occurred on 25 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: we have about 25 spinal trays that we believe have bad bupivacaine in them.
 
Manufacturer Narrative
Investigation summary: no samples were received for evaluation.The investigation was not able to identify or confirm any contribution to the reported failure mode from the factors noted above.Specific to the handling of the drugs, the investigation noted specific procedures to control the handling of any raw material drug component during the receipt, storage, and use in the manufacturing process.A review of the temperature monitoring system within the (b)(6) facility did not identify any excursions that would have negatively affected any of the raw material drug components used within this product code.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.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.A device history record review of all applicable manufacturing records for lot 0001302639 did not identify any issues that may have contributed to the reported failure mode.
 
Event Description
Material no: 405671, batch no: 0001302639.It was reported that during use of the tray spn whit25g3.5 l/b-d/e plast drape the trays have bad bupivacaine in them.This occurred on 25 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: we have about 25 spinal trays that we believe have bad bupivacaine in them.
 
Manufacturer Narrative
H6.Investigation: no samples were received for evaluation.The investigation was not able to identify or confirm any contribution to the reported failure mode from the factors noted above.Specific to the handling of the drugs, the investigation noted specific procedures to control the handling of any raw material drug component during the receipt, storage, and use in the manufacturing process.A review of the temperature monitoring system within the mannford facility did not identify any excursions that would have negatively affected any of the raw material drug components used within this product code.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.A device history record review of all applicable manufacturing records for lot 0001302639 did not identify any issues that may have contributed to the reported failure mode.H3 other text : see h10.
 
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Brand Name
TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key9129816
MDR Text Key195566092
Report Number1625685-2019-00116
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904056711
UDI-Public00382904056711
Combination Product (y/n)N
PMA/PMN Number
DISCRETION
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup,Followup
Report Date 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2021
Device Model Number405671
Device Catalogue Number405671
Device Lot Number0001302639
Date Manufacturer Received02/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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