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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

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE Back to Search Results
Catalog Number 320440
Device Problems Detachment Of Device Component (1104); Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/20/2017
Event Type  malfunction  
Manufacturer Narrative
Date received by manufacturer correction. The date received by manufacturer field has been updated to reflect the corrected date of 12/20/2017.
 
Manufacturer Narrative
Investigation results. Severity: s1; occurrence: a complaint history check was performed and this is the 1st related complaint for plunger rod difficult to move and the 1st related complaint for stopper separates on lot # 7177921. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed. As per manufacturing, a review of the device history record was completed for batch # 7177921 all inspections were performed per the applicable operations qc specifications. There were zero (0) notifications noted that pertained to the complaint. Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned. The root cause is undetermined. If samples are received in the future the complaint will be reopened for further investigation. Based on the above, no additional investigation and no capa is required at this time.
 
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 by a medical professional that there was difficult plunger movement while using bd insulin syringes with the bd ultra-fine¿ needles; stating the ¿plunger rods are stiff and stopper separates. ¿ there was no report of injury or medical intervention.
 
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Brand NameBD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Type of DeviceINSULIN SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7187754
MDR Text Key263791492
Report Number1920898-2017-00435
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup,Followup
Report Date 02/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number320440
Device Lot Number7177921
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/12/2018 Patient Sequence Number: 1
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