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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE MINIMED® PRO-SET® WITH BD FLOWSMART¿ TECHNOLOGY, 24 IN X 6 MM INTRAVASCULAR ADMINISTRATION SET

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BD MEDICAL - DIABETES CARE MINIMED® PRO-SET® WITH BD FLOWSMART¿ TECHNOLOGY, 24 IN X 6 MM INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 328614
Device Problems Bent (1059); Detachment Of Device Component (1104)
Patient Problems Hyperglycemia (1905); Vomiting (2144); No Patient Involvement (2645)
Event Date 11/09/2016
Event Type  Injury  
Manufacturer Narrative
Results: a sample is not available for evaluation. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6207535. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode. Additionally, situational analysis (b)(4) and capa (b)(4) have been opened to address elevated glucose levels associated with this device. (b)(4).
 
Event Description
It was reported that the needle of a minimed® pro-set® with bd flowsmart¿ technology, 24 in x 6 mm was bent and not in a diabetic patient's body which led to increased blood glucose levels and vomiting. The patient's blood glucose level at the time of the incident was 300 mg/dl and he was hospitalized for dka on (b)(6) 2016 at 2:30pm. The patient was discharged on (b)(6) 2016 at 3:00 pm. The details of any medical treatment the patient may have received while hospitalized were not provided.
 
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Brand NameMINIMED® PRO-SET® WITH BD FLOWSMART¿ TECHNOLOGY, 24 IN X 6 MM
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
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
8015652845
MDR Report Key6167289
MDR Text Key62184002
Report Number1920898-2016-00046
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160651
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation
Type of Report Initial
Report Date 12/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue Number328614
Device Lot Number6207535
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/12/2016 Patient Sequence Number: 1
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