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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1ML 26GA 12.7MM 10BAG 500CAS S-Q PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 1ML 26GA 12.7MM 10BAG 500CAS S-Q PISTON SYRINGE Back to Search Results
Catalog Number 305501
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 01/12/2021
Event Type  malfunction  
Manufacturer Narrative
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 the syringe 1ml 26ga 12. 7mm 10bag 500cas s-q packaging seal was "weak" and had come loose. The following information was provided by the initial reporter, translated from spanish to english: "we have found that the sachets containing these syringes are poorly sealed. " in some, the seal is very weak, and it is open or almost open. In others, it has a double seal, the first has come loose, but there is another heat seal that is very close to the edge. Photo 4 is a well-closed unit: it has a double seal, and although the lower one has been opened, the last heat seal (more on the edge) is complete.
 
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Brand NameSYRINGE 1ML 26GA 12.7MM 10BAG 500CAS S-Q
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11312173
MDR Text Key231398149
Report Number1920898-2021-00180
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSP
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 02/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305501
Device Lot Number9343837
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 Received02/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2019
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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