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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 1/2IN 90 BX 450 MO PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 1/2IN 90 BX 450 MO PISTON SYRINGE Back to Search Results
Model Number 328280
Device Problem Defective Device (2588)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that a syringe 0. 3ml 1/2in 90 bx 450 mo was damaged before use. The following was reported by the initial reporter: "it was reported that the plunger cap is damaged and appears to be chewed. Also, the plunger rod is damaged and the thumb press is missing. Verbatim: consumer reported that the plunger cap is damaged, appears to be chewed up. Also reported plunger rod damaged, stated that the thumb press is missing. Lot #: 9259108. Catalog #: 328280. Date of event: unknownsamples: available - sending mail kit".
 
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Brand NameSYRINGE 0.3ML 1/2IN 90 BX 450 MO
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
8015296192
MDR Report Key11248295
MDR Text Key243845199
Report Number1920898-2021-00124
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number328280
Device Catalogue Number328280
Device Lot Number9259108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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