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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II INSULIN SYRINGE

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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II INSULIN SYRINGE Back to Search Results
Catalog Number 326719
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/19/2018
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: 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 consumer that there has been problems with the plungers detaching on bd ultra-fine¿ ii insulin syringe during use. There was no report of exposure, injury or medical intervention.
 
Manufacturer Narrative
Investigation results: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. Unable to perform dhr check due to unknown lot number for stopper separates, needle shield separates, needle clog, barbed needle, and bent needle. Severity: s_2__; occurrence: unable to perform complaint lot history check due to unknown lot number for stopper separates, needle shield separates, needle clog, barbed needle, and bent needle. 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. Based on the above, no additional investigation and no capa is required at this time. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. If samples are received in the future the complaint will be reopened for further investigation.
 
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Brand NameBD ULTRA-FINE¿ II INSULIN SYRINGE
Type of DeviceINSULIN SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7381942
MDR Text Key104035879
Report Number1920898-2018-00184
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K941657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number326719
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/29/2018 Patient Sequence Number: 1
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