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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 31GA 6MM; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 31GA 6MM; PISTON SYRINGE Back to Search Results
Catalog Number 324909
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
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 1 bd syringe 0.3ml 31ga 6mm had product damage issues.The following information was provided by the initial reporter : the consumer reported that the syringe barrels are bent over like a boomerang and the packages are sealed.The consumer stated that the entire box is affected.Date of event : unknown.Samples : available.
 
Manufacturer Narrative
H.6.Investigation: customer returned (1) loose 0.3ml bd insulin syringe from lot# 1018132.The consumer reported that the syringe barrels are bent over like a boomerang.The returned syringe was examined, and it was observed that the barrel was damaged between the 5-10 unit marks causing the barrel to appear bent/bowed.A review of the device history record was completed for batch# 1018132.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint.Root cause: l2l maintenance dispatch for damaged barrels generated on 11mar2020 at the assembly operation.The printed barrels where getting caught in the rail going into the prep dial and at the prep dial inhabit gate.
 
Event Description
It was reported that 1 bd syringe 0.3ml 31ga 6mm had product damage issues.The following information was provided by the initial reporter : the consumer reported that the syringe barrels are bent over like a boomerang and the packages are sealed.The consumer stated that the entire box is affected.Date of event : unknown, samples : available.
 
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Brand Name
BD SYRINGE 0.3ML 31GA 6MM
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key12536842
MDR Text Key273581514
Report Number1920898-2021-01017
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 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number324909
Device Lot Number1018132
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2021
Date Manufacturer Received09/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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