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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ANESTHESIA KIT ANESTHESIA SYRINGE

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BECTON DICKINSON UNSPECIFIED BD ANESTHESIA KIT ANESTHESIA SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 08/13/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4). Unknown manufacturer: (b)(4).
 
Event Description
It was reported that an unspecified anesthesia tray had anesthesia that failed to work. The following information was provided by the initial reporter: "it was reported that: the kit is not the correct potency. "i also had another patient with a low spinal level where i had to supplement with ketamine. " event description states: this is what i got from our anaesthesiologist. It has happened multiple times in the last few months so no specific lot#. Can you please send over contact info and let me know what you need from me to file a formal quality complaint. By failure we mean while placing the spinal everything seemed perfect but the spinal did not take effect properly. Dr. (b)(6) spinal set in but then wore off very quickly. In my two one patient had good analgesia and were able to complete the surgery but they could still move their surgical leg. In another one dermatome wasn't numb but the rest of the abdomen was for a c-section. I also had another patient with a low spinal level where i had so supplement with ketamine. Dr. (b)(6) also had 2 failures but i don't know the details. I think there is something wrong with the hyperbaric bupivacaine included in the kit. Its like the medication is not the correct potency so the patients are getting under dosed. ".
 
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Brand NameUNSPECIFIED BD ANESTHESIA KIT
Type of DeviceANESTHESIA SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10497367
MDR Text Key207024762
Report Number2243072-2020-01370
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2020
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 Treatment Data
Date Received: 09/04/2020 Patient Sequence Number: 1
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