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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD¿ TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE; ANESTHESIA CONDUCTION KIT
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CAREFUSION, INC BD¿ TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405672
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Inadequate Pain Relief (2388)
Event Date 02/27/2019
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that during the c-section, two bd¿ tray spn whit25g3.5 l/b-d/e blue drape did not set up promptly, which made patient still have the sensation below spinal injection, resulted in the use of general anesthesia for this patient instead of localized anesthesia.This made the baby was exposed unnecessarily to general anesthesia agents.Post the surgery, the patient had adequate pain relief and side effects such as itching from the duramorph, which was injected into the same site.According to the customer, beside this event for this patient, there have been multiple events happened.Customer¿s verbatim: ¿ medication is injected and the patient¿s spinal does not set up promptly (she still has sensation below spinal injection) causing us to use general anesthesia.This is occurring for c-sections.The baby is then exposed to unnecessary general anesthetic agents and the mother is not able to be awake to see her baby.Post op the patient has adequate pain relief and side effects such as itching from the duramorph that was injected into the same site." additional information per customer's email states, "we continue to have concerns with spinal anesthesia tray 405672.We had an event today.There have been multiple events.The lot number is 0001276810.The spinal did not set up and the patient received general anesthesia.We do not seem to be having concerns with the needles or delivering the medication.Please send resolution from your quality team asap on the drugs provided by pfizer.".
 
Manufacturer Narrative
Correction: type of reportable events: serious injury.Investigation summary: no sample was returned for analysis.A review of the device history record was performed and no quality issues were found during production.The investigation was not able to identify or confirm any contribution to the reported failure mode.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.The investigation did identify this failure mode as a previously known issue.Based on the complaint investigation, a probable root cause could not be identified for the reported failure mode.The investigation identified a previous capa (capa 67717) performed by the bd anesthesia quality group that specifically investigated the ¿ineffective anesthesia¿ failure mode.Likewise, the investigation identified a summary for previously investigated complaints which provides rationale and information regarding the potential ineffective anesthesia outcome during the use of an anesthesia product code.It states that, "ineffective anesthesia during clinical procedures results from a variety of causes." based on a review of all of these sources, the current complaint investigation could not identify a definitive root cause nor could any potential contributor be identified for this specific complaint failure mode.
 
Event Description
It was reported that during the c-section, two bd¿ tray spn whit25g3.5 l/b-d/e blue drape did not set up promptly, which made patient still have the sensation below spinal injection, resulted in the use of general anesthesia for this patient instead of localized anesthesia.This made the baby was exposed unnecessarily to general anesthesia agents.Post the surgery, the patient had adequate pain relief and side effects such as itching from the duramorph, which was injected into the same site.According to the customer, beside this event for this patient, there have been multiple events happened.
 
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Brand Name
BD¿ TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key8426823
MDR Text Key139312306
Report Number1625685-2019-00018
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904056728
UDI-Public00382904056728
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
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2021
Device Catalogue Number405672
Device Lot Number0001276810
Date Manufacturer Received02/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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