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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP

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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP Back to Search Results
Catalog Number 326631
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Date received by manufacturer: bd was initially made aware of this complaint on (b)(6) 2021. At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident. Additional information was later received on 2021-08-09 that changed the reportability determination. Based on the additional information received, this complaint is now considered to be an mdr reportable incident. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that syringe 0. 3 ml 29 ga 1/2 in 7 bag 420cas (b)(4) hub separated. The following information was provided by the initial reporter: there was no needle assembled in the product.
 
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Brand NameSYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP
Type of DeviceSYRINGE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12316449
MDR Text Key266418355
Report Number1920898-2021-00888
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number326631
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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