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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 326785
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2024
Event Type  malfunction  
Manufacturer Narrative
H.3.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 while using the bd ultra-fine 6mm¿ jeringa para insulina 0,3ml 31g x 6mm u-100 10x3count syringe, droplets were found.The following information was provided by the initial reporter, translated from spanish to english: air and clear liquid in the syringe through the needle a drop of water, -- additional comments: insulin syringes report.Diabetic.I bought insulin syringes 1 week ago and when i take the syringe it comes with air, i take out the air before using it and when i press it, a little water comes out, a drop of water, a drop of water, a drop of water, a drop of water, a drop of water.I take out the air before using it and when i press it a little bit of water comes out, a little drop of transparent color.Bag 1 had a syringe with this defect and the 2nd bag also had several syringes with the same and there i said that it was not normal, the 3rd bag is still not used, it is still in its packaging, in total there are 5 defective syringes.
 
Event Description
It was reported while using the bd ultra-fine 6mm¿ jeringa para insulina 0,3ml 31g x 6mm u-100 10x3count syringe, droplets were found.The following information was provided by the initial reporter, translated from spanish to english: air and clear liquid in the syringe through the needle a drop of water, -- additional comments: insulin syringes report.Diabetic.I bought insulin syringes 1 week ago and when i take the syringe it comes with air, i take out the air before using it and when i press it, a little water comes out, a drop of water, a drop of water, a drop of water, a drop of water, a drop of water.I take out the air before using it and when i press it a little bit of water comes out, a little drop of transparent color.Bag 1 had a syringe with this defect and the 2nd bag also had several syringes with the same and there i said that it was not normal, the 3rd bag is still not used, it is still in its packaging, in total there are 5 defective syringes.
 
Manufacturer Narrative
H.6.Investigation summary: no physical samples were received however the investigation was performed based on the photo(s) provided.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Embecta was unable to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.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.Based on the above, no additional investigation and no corrective/preventative action (capa) or situation analysis (sa) is required at this time.
 
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Brand Name
BD ULTRA-FINE INSULIN SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key18564282
MDR Text Key333509074
Report Number1920898-2024-00015
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number326785
Device Lot Number3023409
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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