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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNSPECIFIED BD SPINAL/EPIDURAL NEEDLE/TRAY; ANESTHESIA KIT
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UNSPECIFIED BD SPINAL/EPIDURAL NEEDLE/TRAY; ANESTHESIA KIT Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.
 
Event Description
It was reported that the unspecified bd spinal/epidural needle/tray experienced ruptured tubing.The following information was provided by the initial reporter: it has a resistance while entering, not very handy, and it may also ruptures sometimes.
 
Manufacturer Narrative
H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Dhr could not be performed due to unknown lot#.The complaint could not be confirmed and the root cause is undetermined.
 
Event Description
It was reported that the unspecified bd spinal/epidural needle/tray experienced ruptured tubing.The following information was provided by the initial reporter: it has a resistance while entering, not very handy, and it may also ruptures sometimes.
 
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Brand Name
UNSPECIFIED BD SPINAL/EPIDURAL NEEDLE/TRAY
Type of Device
ANESTHESIA KIT
MDR Report Key11646647
MDR Text Key253140431
Report Number2243072-2021-01097
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,health professional,o
Type of Report Initial,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2021
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
Date Manufacturer Received04/12/2021
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
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