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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 30GA 8MM; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 30GA 8MM; PISTON SYRINGE Back to Search Results
Catalog Number 328322
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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 7 bd syringe 0.3ml 30ga 8mm hubs separated from the device.The following information was provided by the initial reporter : the clinic employee reported that when removing the orange protective cover the needle gets stuck in the cover making it impossible to use.
 
Event Description
It was reported that 7 bd syringe 0.3ml 30ga 8mm hubs separated from the device.The following information was provided by the initial reporter : the clinic employee reported that when removing the orange protective cover the needle gets stuck in the cover making it impossible to use.
 
Manufacturer Narrative
H6: investigation summary.No samples were returned therefore the investigation was performed based on the photos provided.Three photos were provided.The customer reported when removing the orange protective cover the needle gets stuck in the cover making it impossible to use.All three photos were examined, and it was observed that the needle hub/shield assembly was detached from the syringe.No damage was observed on the barrel tip.A review of the device history record was completed for batch # 0189401 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure based on the photos received.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Capa pr1630423 has been opened to address this issue.H3 other text: see h10.
 
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Brand Name
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 Key12305073
MDR Text Key265982509
Report Number1920898-2021-00881
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,use
Type of Report Initial,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328322
Device Lot Number0189401
Was Device Available for Evaluation? No
Date Manufacturer Received08/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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