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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD PRECISION GLIDE¿ ALLERGY SYRINGE/NEEDLE; SYRINGE WITH NEEDLE
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BD MEDICAL - DIABETES CARE BD PRECISION GLIDE¿ ALLERGY SYRINGE/NEEDLE; SYRINGE WITH NEEDLE Back to Search Results
Model Number 305536
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd precision glide¿ allergy syringe/needle the tip/luer of the syringe broke off.The following information was provided by the initial reporter.The customer stated: the medical professional reported, "the heads of the syringe are falling/breaking off.".
 
Manufacturer Narrative
H6: investigation summary: customer returned a photo of a 1/2ml syringe.Customer states that the heads of the syringe are falling/breaking off.The photo was examined and exhibited the hub-needle/shield assembly separated from the barrel.A review of the device history record was completed for batch # 0104220.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure (hub separates).Capa (b)(4) has been opened to address this issue.H3 other text: see h10.
 
Event Description
It was reported when using the bd precision glide¿ allergy syringe/needle the tip/luer of the syringe broke off.The following information was provided by the initial reporter.The customer stated: the medical professional reported, "the heads of the syringe are falling/breaking off.".
 
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Brand Name
BD PRECISION GLIDE¿ ALLERGY SYRINGE/NEEDLE
Type of Device
SYRINGE WITH NEEDLE
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 Key12709960
MDR Text Key278794205
Report Number1920898-2021-01115
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903055365
UDI-Public30382903055365
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number305536
Device Catalogue Number305536
Device Lot Number0104220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2020
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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