• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR ANESTHESIA CONDUCTION KIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION, INC 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 400866
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0001301412, medical device expiration date: 2021-03-31, device manufacture date: 2019-05-10. Medical device lot #: 0001284188, medical device expiration date: 2021-04-30, device manufacture date: 2019-01-30. Medical device lot #: 0001280749, medical device expiration date: 2021-04-30, device manufacture date: 2019-01-10. 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 ineffective anesthesia occurred during use with a 25gx3. 5in whit 5ml glaspak bupi clear. The following information was provided by the initial reporter, "it was reported that 2 more c/ sections with the incident date unknown took place and were performed where the crna had issue with the spinals anesthesia- bupivacaine being questionable as ineffective (lot # 0001280749). Then a week later 2 more c/ sections were performed, date of incident for this event is unknown at the moment and it involved two lot numbers (0001284188 & 0001301412). Per email: hi, here is the information for the complaint. Do you want to add this to the existing pr or create a new one? at this time we only have the tray lot information, we do not have the drug lot information. Recently started using new bd spinal kits (previously arrow). Last week, ob had two c/sections in which the spinals didn¿t take. Both spinals were put in by the same crna. The first c/s, he repeated the spinal which provided the patient relief. The 2nd c/s, he gave additional iv meds. A safety opportunity was entered for this, and after discussing these cases with the crna, we thought maybe the medication within the spinal kit was not as effective, so we pulled all spinal kits with that lot number (0001280749) from the ob stock and from general stores. Today, we had two more c/sections (different lot numbers than previously), and according to crna, he had issues with these spinals as well. He said he talked to the doctor about this, and the doctor indicated they were having an issue with these same spinal kits, and were pulling them from the shelves. Can you please check with the doctor on this? if they are having the same issues as we are, and the kits are being pulled, both locations should probably be doing the same. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer (Section G)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9364281
MDR Text Key195093327
Report Number1625685-2019-00130
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
DISCRETION
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number400866
Device Lot NumberSEE. H.10
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2019
Was Device Evaluated by Manufacturer? No
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: 11/22/2019 Patient Sequence Number: 1
-
-