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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINAL NEEDLE 27GA 3.50 IN FOR INDIA; ANESTHESIA CONDUCTION NEEDLE
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SPINAL NEEDLE 27GA 3.50 IN FOR INDIA; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
Catalog Number 405127
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 12 spinal needles 27ga 3.50 in for india were found "rusted" inside their packaging units.The following information was provided by the initial reporter: "found rusted spinal needle 27g.During delivering product to customer it was found that spinal needle inside packing is rusted".
 
Event Description
It was reported that 12 spinal needles 27ga 3.50 in for india were found "rusted" inside their packaging units.The following information was provided by the initial reporter: "found rusted spinal needle 27g.During delivering product to customer it was found that spinal needle needle inside packing is rusted".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/25/2021.H.6.Investigation: three photos and three samples were provided to our quality team for investigation.Through visual inspection of the photos, brown stains are observed, however, there was no evidence of rust or corrosion on the samples returned.A review of the device history was performed for the lot 2001005, no deviations or nonconformities were identified during the manufacturing process that could have contributed to this problem.Five retained samples of the lot 2001005 were used for additional evaluation.Using magnification, the product was visually inspected and no corrosion or other staining was observed.Product is visually and functionally inspected throughout the manufacturing process in accordance with procedure, verifying that all critical dimensions are within specification and that there are no product damages or defects.All records have been reviewed and no problems were identified during the inspections of the reported batches.Based on the available information, we are unable to identify a definitive root cause at this time.
 
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Brand Name
SPINAL NEEDLE 27GA 3.50 IN FOR INDIA
Type of Device
ANESTHESIA CONDUCTION NEEDLE
MDR Report Key11441186
MDR Text Key265828624
Report Number3003152976-2021-00131
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/29/2024
Device Catalogue Number405127
Device Lot Number1903012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2021
Date Manufacturer Received03/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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