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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE; PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 326666
Device Problem Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2023
Event Type  malfunction  
Event Description
It was reported that the bd ultra-fine¿ 1/2ml insulin syringe experienced hub separation from the device.The following information was provided by the initial reporter: this is a report about needle/shied separation.According to the customer's report, the needle with the shied was separated from the barrel when the shield was removed.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 23-mar-2023.H6: investigation summary: customer returned one 0.3 ml syringe inside a small zipper bag.It was reported from the customer that the needle with the shied was separated from the barrel when the shield was removed.The returned syringe was visually inspected, and no issues were found.The hub and the shield were attached properly.The shieled then was removed and attached more than 10 times and did not cause any hub separation.Due to the batch being unknown, no dhr review can be completed.Based on the samples received, embecta was not able to confirm the customer¿s indicated failure.Since the issue is not confirmed, the root cause can not be determined.H3 other text : see h10.
 
Event Description
It was reported that the bd ultra-fine¿ 1/2ml insulin syringe experienced hub separation from the device.The following information was provided by the initial reporter: this is a report about needle/shied separation.According to the customer's report, the needle with the shied was separated from the barrel when the shield was removed.
 
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Brand Name
BD ULTRA-FINE¿ 1/2ML 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
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key16524789
MDR Text Key311253123
Report Number1920898-2023-00110
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 06/02/2023
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 Number326666
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/16/2023
Initial Date FDA Received03/10/2023
Supplement Dates Manufacturer Received06/02/2023
Supplement Dates FDA Received06/15/2023
Was Device Evaluated by Manufacturer? Yes
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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