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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG PISTON SYRINGE Back to Search Results
Model Number 928856
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
 
Event Description
It was reported syringe 1. 0ml 31ga 8mm 10bag 500 pl/wg had a plunger rod that was difficult to move. The following information was provided by the initial reporter: "family member of consumer reported plunger rod difficult to move. ".
 
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Brand NameSYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG
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 Key12550675
MDR Text Key274488979
Report Number1920898-2021-01029
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 Other Health Care Professional
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number928856
Device Catalogue Number928856
Device Lot Number0125633
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 Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2020
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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