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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 30GA 1/2IN UF; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 30GA 1/2IN UF; PISTON SYRINGE Back to Search Results
Catalog Number 328431
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date : unknown.A device evaluation is pending but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date : unknown.
 
Event Description
It was reported that 1 syringe 0.3ml 30ga 1/2in uf hub separated.The following information was provided by the initial reporter : the consumer reported that when the needle shield was removed prior to injection the needle hub separated.Date of event: (b)(6) 2021.Samples: yes.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-07-13.Investigation summary: customer returned two syringes with no pouch for identification.Both syringes feature 0.5ml graduation markings.The first syringe had its needle shield and hub separate from the barrel.The hub has become lodged inside the shield.There is no damage to either the connector at the distal tip of the barrel or its respective needle hub.No signs of use and no other defects found.Due to the batch being unknown, no dhr review can be completed.Based on the samples received, bd was able to confirm the customer¿s indicated failure of needle hub separation.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.Capa pr1630423 has been opened to address this issue.H3 other text : see h10.
 
Event Description
It was reported that 1 syringe 0.3ml 30ga 1/2in uf hub separated.The following information was provided by the initial reporter : the consumer reported that when the needle shield was removed prior to injection the needle hub separated.Date of event: (b)(6) 2021.Samples: yes.
 
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Brand Name
SYRINGE 0.3ML 30GA 1/2IN UF
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key12157934
MDR Text Key261232281
Report Number1920898-2021-00745
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 consumer,other
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328431
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Date Manufacturer Received07/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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