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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II SHORT-NEEDLE INSULIN SYRINGE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II SHORT-NEEDLE INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 328838
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2023
Event Type  malfunction  
Manufacturer Narrative
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¿ ii short-needle insulin syringe was broken.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "the syringe is broken.".
 
Event Description
It was reported that the bd ultra-fine¿ ii short-needle insulin syringe was broken.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "the syringe is broken.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 17-apr-2023.H6: investigation summary customer returned total of (6) 0.5ml 31ga 8mm syringes in two open polybags from the lot# 1221864.It was reported by the consumer that the syringe broken.Returned samples were visually examined and observed one syringe with damaged shield, unable to detach the shield from syringe.A review of the device history record was completed for batch #1221864.All inspections and challenges were performed per the applicable operations qc specifications.Embecta was able to confirm the customer indicated failure.No root cause can be determined.
 
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Brand Name
BD ULTRA-FINE¿ II SHORT-NEEDLE 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
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16640163
MDR Text Key312498058
Report Number1920898-2023-00167
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/03/2023
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 Number328838
Device Lot Number1221864
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/13/2023
Initial Date FDA Received03/29/2023
Supplement Dates Manufacturer Received08/03/2023
Supplement Dates FDA Received08/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2021
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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