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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:
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Device Problem Improper Flow or Infusion (2954)
Patient Problem Hypoglycemia (1912)
Event Type  Injury  
Event Description
It was reported that after 3 days rest, another smiths medical catheter was used from the box and hyperglycemia occurred again.No further adverse patient effects were reported.
 
Manufacturer Narrative
Other text:, corrected data: event described was listed as occurring with another company's product (medtronic set and not smiths medical).
 
Event Description
Event described was listed as occurring with another company's product (medtronic set and not smiths medical).Incident reported inadvertently.
 
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MDR Report Key11085352
MDR Text Key224024349
Report Number3012307300-2020-12786
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 01/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/30/2020
Initial Date FDA Received12/28/2020
Supplement Dates Manufacturer Received12/28/2020
Supplement Dates FDA Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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