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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD INSULIN SYRINGE SYRINGE, PISTON

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BD BD INSULIN SYRINGE SYRINGE, PISTON Back to Search Results
Device Problem Entrapment of Device (1212)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Device Embedded In Tissue or Plaque (3165)
Event Date 09/09/2019
Event Type  Injury  
Event Description
Caller reported syringe needle broke and was entrapped in her stomach. She went to the er and had an x-ray, however the needle could not be visualized. The surgeon informed her to return if there are signs of infection. On (b)(6) 2019, caller noticed an infection and inflammation in her abdomen. She returned to the surgeon and had the needle removed on (b)(6) 2019.
 
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Brand NameBD INSULIN SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BD
MDR Report Key9315967
MDR Text Key166353361
Report NumberMW5091013
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/12/2019 Patient Sequence Number: 1
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