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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Model Number 328290
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2023
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 that the needle of the bd insulin syringe with the bd ultra-fine¿ needle was missing when removing the needle hub.The following information was provided by the initial reporter: "stated, when he removed needle hub on another syringe, the needle was missing completely".
 
Event Description
It was reported that the needle of the bd insulin syringe with the bd ultra-fine¿ needle was missing when removing the needle hub.The following information was provided by the initial reporter: "stated, when he removed needle hub on another syringe, the needle was missing completely.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 22-mar-2023.H6: investigation summary customer returned one ½ ml ¿ 31g syringe inside the open polybag.It was reported by the consumer that needle hub separated, insulin leaked, and another syringe had missing cannula.The syringe was returned with the hub separated and stuck inside the shield.During the investigation we were able to attach the hub back to the syringe and the shield was able to be removed properly without separating the hub.The syringe then was tested for leakage using tub water and was observed water bubbles coming from the connection of the hub with the syringe.Since the other syringe was not returned, we were not able to confirm the missing canula.A review of the device history record was completed for batch# 1347526.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples received, embecta was able to confirm the customer¿s indicated failure.Root cause analysis: there was one notification for cracked barrels found in assembled syringes that pertained to the complaint.This was due to jamming at the infeed dial due to misplaced sensor.Correction: as per the notification the sensor(eye) was adjusted in proper position and tightened; as well as adjusted the machine so that it would get less jams.
 
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Brand Name
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
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 Key16475887
MDR Text Key310605841
Report Number1920898-2023-00081
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903282906
UDI-Public00382903282906
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number328290
Device Catalogue Number328290
Device Lot Number1347526
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received06/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2021
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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