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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 0.5 ML BD MICRO-FINE¿ + INSULIN SYRINGE WITH 30G X 12.7 MM NEEDLE

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BD MEDICAL - DIABETES CARE 0.5 ML BD MICRO-FINE¿ + INSULIN SYRINGE WITH 30G X 12.7 MM NEEDLE Back to Search Results
Catalog Number 324824
Device Problem Product Quality Problem (1506)
Patient Problem No Code Available (3191)
Event Date 09/12/2017
Event Type  Injury  
Manufacturer Narrative
Investigation summary: customer returned (90) 1/2cc, 12. 7mm, 29g syringes in sealed poly bags with the shelf carton from lot # 6172630. Customer states that silicone from the syringe was injected into the eye of several patients. Thirty out of 90 returned syringes were examined visually and under the microscope and no foreign matter was observed on or in any of the samples. All of these samples were also tested and no material came out of the syringe when fully depressing the plunger rod. As per manufacturing, a review of the device history record was completed for batch# 6172630. All inspections and challenges were performed per the applicable operations qc specifications. There was one (1) notification [(b)(4)] 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 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. Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure. Root cause description: root cause cannot be determined at this time as the issue is unconfirmed.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that when medication injected from a 0. 5 ml bd micro-fine¿ + insulin syringe with 30g x 12. 7 mm needle particles of silicon from the syringe were also injected into the eyes of patients. Injury and medical intervention are unknown.
 
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Brand Name0.5 ML BD MICRO-FINE¿ + INSULIN SYRINGE WITH 30G X 12.7 MM NEEDLE
Type of DeviceINSULIN 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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6947093
MDR Text Key251928232
Report Number1920898-2017-00233
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K941657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Expiration Date06/30/2021
Device Catalogue Number324824
Device Lot Number6172630
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/12/2017 Patient Sequence Number: 1
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