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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 328290
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2023
Event Type  malfunction  
Event Description
It was reported by the consumer that 2 boxes of the bd ultra-fine¿ insulin syringe were unable to inject insulin.The following was received by the initial reporter: 1 needle was clogged.Several syringes were able to be aspirated, but were unable to be injected.
 
Manufacturer Narrative
E.1.The customer's address is (b)(6).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.H3 other text : see h.10.
 
Event Description
It was reported by the consumer that 2 boxes of the bd ultra-fine¿ insulin syringe were unable to inject insulin.The following was received by the initial reporter: 1 needle was clogged.Several syringes were able to be aspirated, but were unable to be injected.
 
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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 Key18022772
MDR Text Key326848899
Report Number1920898-2023-00742
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903282906
UDI-Public(01)00382903282906
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328290
Device Lot Number0021841
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/21/2020
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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