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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

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BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGE Back to Search Results
Catalog Number 329416
Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/08/2018
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that the needle of a bd¿ ultra-fine insulin syringe broke off and remained in the medication vial.There was no report of injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.A review of the device history record was completed for batch# 7030668.All inspections were performed per the applicable operations qc specifications.There were four notifications noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.
 
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Brand Name
BD ULTRA-FINE INSULIN SYRINGE
Type of Device
INSULIN SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7237436
MDR Text Key98914448
Report Number1920898-2018-00016
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903294169
UDI-Public00382903294169
Combination Product (y/n)N
PMA/PMN Number
K170386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 04/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number329416
Device Lot Number7030668
Initial Date Manufacturer Received 01/10/2018
Initial Date FDA Received02/02/2018
Supplement Dates Manufacturer Received01/10/2018
Supplement Dates FDA Received04/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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