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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 324892
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2023
Event Type  malfunction  
Event Description
It was reported that the bd ultra-fine¿ insulin syringe was damaged but operable.The following information was provided by the initial reporter, translated from dutch to english: customer says this needle is unsafe.Needle case was loose when used.Patient was restless with arms.Morphine administered with small syringe.Near puncture incident.
 
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 that the bd ultra-fine¿ insulin syringe was damaged but operable.The following information was provided by the initial reporter, translated from dutch to english: customer says this needle is unsafe.Needle case was loose when used.Patient was restless with arms.Morphine administered with small syringe.Near puncture incident.
 
Manufacturer Narrative
H.6.Investigation summary: no samples were returned therefore the investigation was performed based on the photo(s) provided.Embecta was able to confirm the customer-indicated issue.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.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 situational 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 Key18447876
MDR Text Key332154037
Report Number1920898-2024-00001
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeNL
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 02/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number324892
Device Lot Number3044844
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2023
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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