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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 1.0ML 29GA 1/2IN BLS 400 SG; SAFETY SYRINGE
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BD MEDICAL - DIABETES CARE BD SYRINGE 1.0ML 29GA 1/2IN BLS 400 SG; SAFETY SYRINGE Back to Search Results
Catalog Number 305930
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2021
Event Type  malfunction  
Event Description
It was reported when using the bd syringe 1.0ml 29ga 1/2in bls 400 sg, the device experienced product is damaged (broken, missing, unassembled).This event occurred 100 times.The following information was provided by the initial reporter.The customer stated:   safety insulin syringe & needle is missing safety caps (full box).
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 1076976.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.H3 other text : see h10.
 
Event Description
It was reported when using the bd syringe 1.0ml 29ga 1/2in bls 400 sg, the device experienced product is damaged (broken, missing, unassembled).This event occurred 100 times.The following information was provided by the initial reporter.The customer stated:   safety insulin syringe & needle is missing safety caps (full box).
 
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Brand Name
BD SYRINGE 1.0ML 29GA 1/2IN BLS 400 SG
Type of Device
SAFETY 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13005916
MDR Text Key284386120
Report Number1920898-2021-01304
Device Sequence Number1
Product Code MEG
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K992734
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 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305930
Device Lot Number1076976
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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