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

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.".

• Brand Name: UNSPECIFIED BD ANESTHESIA KIT
• Type of Device: ANESTHESIA SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10497367
• MDR Text Key: 207024762
• Report Number: 2243072-2020-01370
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• 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 Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Other