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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 PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 324918
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/18/2020
Event Type  Injury  
Manufacturer Narrative
Date of birth: unknown. The patient¿s age was used to calculate a placeholder date for this field. (b)(6). 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 that the bd ultra-fine¿ insulin syringe needle broke off inside the patient's stomach near the navel during use. As a result, the consumer went to the emergency room, where an incision was made and the broken needle removed. The following information was provided by the initial reporter, translated from (b)(6) to english: "when injecting insulin in his father, the needle broke and stayed in the patient's belly, close to the navel. He said his father has been using the brand for 25 years and it never happened to him. There was no red or purple at the application site, the patient feels pain due to the needle being inside his belly. Customer took his father to the emergency room. " "additional information: the customer informed by telephone that a small incision was made at the site and the needle was removed, and the patient is not using any type of medication, only a tape and he is doing well. ".
 
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Brand NameBD ULTRA-FINE INSULIN SYRINGE
Type of DevicePISTON 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
8015652341
MDR Report Key10129815
MDR Text Key195756962
Report Number1920898-2020-00630
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number324918
Device Lot Number9077774
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2019
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: 06/08/2020 Patient Sequence Number: 1
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