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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2"; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2"; PISTON SYRINGE Back to Search Results
Catalog Number 326631
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2023
Event Type  malfunction  
Manufacturer Narrative
H3.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¿ 3/10ml insulin syringe 29g x 1/2" separates from the hub.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the needle came off.When the orange cap was removed, the needle also came off.
 
Event Description
It was reported that the bd ultra-fine¿ 3/10ml insulin syringe 29g x 1/2" separates from the hub.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the needle came off.When the orange cap was removed, the needle also came off.
 
Manufacturer Narrative
H6: investigation summary the customer returned (1) 0.3ml 29ga syringe, reporting needle separates.The syringe was visually inspected and observed cannula hub separated from the barrel tip.Based on the sample returned, embecta was able to confirm the customer-indicated failure.A review of the device history record was completed for batch #2192387.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.
 
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Brand Name
BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2"
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
phillip emmert
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17203718
MDR Text Key317942407
Report Number1920898-2023-00390
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJA
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 09/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number326631
Device Lot Number2192387
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/01/2023
Initial Date FDA Received06/26/2023
Supplement Dates Manufacturer Received09/01/2023
Supplement Dates FDA Received09/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2022
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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