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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 30GA 8MM; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 30GA 8MM; PISTON SYRINGE Back to Search Results
Catalog Number 326638
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2021
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.
 
Event Description
It was reported that 2 bd syringe 0.3ml 30ga 8mm hubs separated from the device.The following information was provided by the initial reporter : the customer reported that the needle with the shied was separated from the barrel.
 
Event Description
It was reported that 2 bd syringe 0.3ml 30ga 8mm hubs separated from the device.The following information was provided by the initial reporter : the customer reported that the needle with the shied was separated from the barrel.
 
Manufacturer Narrative
H.6.Investigation: customer returned several images of two 0.3ml, 30 gauge, 8mm syringes from lot 0286309.The syringes had their needle shields and hubs separate from the barrels.The hubs have become lodged inside the shields.There is no damage to either the connectors at the distal tips of the barrels or their respective needle hubs.No signs of use and no other defects found.A review of the device history record was completed for batch # 0286309 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the images received, bd was able to confirm the customer¿s indicated failure of needle hub separation.Capa#1630423 was initiated.H3 other text : see h.10.
 
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Brand Name
BD SYRINGE 0.3ML 30GA 8MM
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key12468431
MDR Text Key271296791
Report Number1920898-2021-00985
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number326638
Device Lot Number0286309
Was Device Available for Evaluation? No
Date Manufacturer Received09/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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