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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD SPINAL NEEDLE 27GA 3.50 IN; ANESTHESIA CONDUCTION NEEDLE
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BD SPINAL NEEDLE 27GA 3.50 IN; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
Catalog Number 405259
Device Problem Material Twisted/Bent (2981)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/13/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that when starting spinal anesthesia the needle was discovered to be defective with a bd spinal needle 27ga 3.50 in.The following information was provided by the initial reporter, translated from spanish to english: patient who, when starting spinal anesthesia when removing the mandrel from the needle, immediately deforms without generating additional pressure on it.Required a new puncture.
 
Manufacturer Narrative
H.6.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lot 1910012, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples of the same lot were used for additional evaluation.The product was visually inspected and no damaged or defects were observed on the product, the stylet could be removed from the spinal needle without issue.Product is inspected throughout the manufacturing process according to procedure, no issues were identified during inspections for the reported lot.Based on the available we are not able to identify a root cause related to our manufacturing process at this time.Complaints received for this device and reported issue will continue to be tracked and trended for future occurrence.H3 other text : see h.10.
 
Event Description
It was reported that when starting spinal anesthesia the needle was discovered to be defective with a bd spinal needle 27ga 3.50 in.The following information was provided by the initial reporter, translated from spanish to english: patient who, when starting spinal anesthesia when removing the mandrel from the needle, immediately deforms without generating additional pressure on it.Required a new puncture.
 
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Brand Name
BD SPINAL NEEDLE 27GA 3.50 IN
Type of Device
ANESTHESIA CONDUCTION NEEDLE
MDR Report Key10119392
MDR Text Key196914089
Report Number3003152976-2020-00240
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 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number405259
Device Lot Number1910012
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/15/2020
Initial Date FDA Received06/04/2020
Supplement Dates Manufacturer Received05/15/2020
Supplement Dates FDA Received07/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2019
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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