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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC 18GX3.5 WEISS 20G CE,5ML LOR LL,27G HYP; ANESTHESIA CONDUCTION KIT
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CAREFUSION, INC 18GX3.5 WEISS 20G CE,5ML LOR LL,27G HYP; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 400840
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2019
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that the 18gx3.5 weiss 20g ce,5ml lor ll,27g hyp broke in half during an epidural when the plunger was halfway through the syringe.The following information was provided by the initial reporter: "this glass syringe broke in half when i was doing an epidural today- i think it's tapered a bit so once the plunger reached halfway it broke- luckily nobody was cut - thought you would want to know for quality".
 
Event Description
It was reported that the 18gx3.5 weiss 20g ce,5ml lor ll,27g hyp broke in half during an epidural when the plunger was halfway through the syringe.The following information was provided by the initial reporter: "this glass syringe broke in half when i was doing an epidural today- i think it's tapered a bit so once the plunger reached halfway it broke- luckily nobody was cut- thought you would want to know for quality".
 
Manufacturer Narrative
Investigation: one sample was provided for evaluation.Sample analysis confirmed the reported failure mode (broken glass syringe).The complaint investigation was able to confirm the reported failure mode; however, no contributing factors were able to be identified as the glass syringe is a supplied part.Consequently, a probable root cause could not be identified for the mannford manufacturing facility based on the investigation results.Since the investigation was not able to identify a probable root cause based on the complaint results, no corrective and/or preventive actions are recommended at this time.A lot number was not provided, as a result a dhr review was unable to be performed.
 
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Brand Name
18GX3.5 WEISS 20G CE,5ML LOR LL,27G HYP
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key8784483
MDR Text Key151013511
Report Number1625685-2019-00070
Device Sequence Number1
Product Code CAZ
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 08/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number400840
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2019
Date Manufacturer Received06/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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