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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANESTHESIA TRAY BASIC SPINAL; ANESTHESIA SYRINGE
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ANESTHESIA TRAY BASIC SPINAL; ANESTHESIA SYRINGE Back to Search Results
Catalog Number 401383
Device Problem Leak/Splash (1354)
Patient Problem Needle Stick/Puncture (2462)
Event Date 04/29/2020
Event Type  Injury  
Manufacturer Narrative
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).
 
Event Description
It was reported that a anesthesia tray basic spinal had a damaged plunger rod.The following information was provided by the initial reporter: "on (b)(6) 2020, physician (b)(6), suffered an accident with a needle for insulin, after the 3ml syringe's plumber (from spinal anesthesia kit), used to perform the anesthetic button, bent and slipped from her hand, causing a perforation.Material injured the physician that was performing the procedure, material # 401383".
 
Event Description
It was reported that a anesthesia tray basic spinal had a damaged plunger rod.The following information was provided by the initial reporter: "on (b)(6) 2020, physician (b)(6), suffered an accident with a needle for insulin, after the 3ml syringe's plumber (from spinal anesthesia kit), used to perform the anesthetic button, bent and slipped from her hand, causing a perforation.Material injured the physician that was performing the procedure, material#: 401383".
 
Manufacturer Narrative
H.6.Investigation summary: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record could not be performed as the lot was unknown.Our quality engineer reviewed the provided photo and observed that the 3ml plunger was damaged.Based off the provided photo the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for evaluation a definitive root cause could not be determined.
 
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Brand Name
ANESTHESIA TRAY BASIC SPINAL
Type of Device
ANESTHESIA SYRINGE
MDR Report Key10155743
MDR Text Key195234024
Report Number9610048-2020-00089
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number401383
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/21/2020
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 Number1
Patient Outcome(s) Other;
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