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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.5ML 8MM 90; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD SYRINGE 0.5ML 8MM 90; PISTON SYRINGE Back to Search Results
Model Number 328290
Device Problems Failure to Deliver (2338); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.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 3 bd syringe 0.5ml 8mm 90 were unable to aspirate and 1 had the hub separated.The following information was provided by the initial reporter : the consumer reported that 3 syringe needles would not draw insulin and when a syringe was pulled from the bag there was no needle or needle shield attached as it was loose inside the bag.Date of event : unknown.Samples : available.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-04.H6: investigation summary : customer returned (4) 31gx8mm, 0.5ml bd insulins syringes from lot# 1032950.The consumer reported that the needle would not draw insulin and stated when she pulled a syringe from the bag there was no needle or needle shield attached - it was loose inside the bag.All 4 returned samples were examined, and it was observed that 1 syringe exhibited a broken barrel tip.The fractured barrel tip was lodged inside a detached hub assembly.The remaining 3 samples did not exhibit hub separation; removing the cannula shields from these 3 samples did not result in hub separation.These 3 samples were tested for flow, and it was observed that all 3 were able to draw and expel properly.A review of the device history record was completed for batch# 1032950.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure (barrel tip broken).Bd was not able to duplicate or confirm the customer¿s indicated failure (not drawing).H3 other text : see h10.
 
Event Description
It was reported that 3 bd syringe 0.5ml 8mm 90 were unable to aspirate and 1 had the hub separated.The following information was provided by the initial reporter : the consumer reported that 3 syringe needles would not draw insulin and when a syringe was pulled from the bag there was no needle or needle shield attached as it was loose inside the bag.Date of event : unknown.Samples : available.
 
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Brand Name
BD SYRINGE 0.5ML 8MM 90
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12557731
MDR Text Key275428758
Report Number1920898-2021-01031
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903282906
UDI-Public00382903282906
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 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number328290
Device Catalogue Number328290
Device Lot Number1032950
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2021
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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