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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD MIDLINE; MIDLINE CATHETER
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C.R. BARD, INC. (BASD) -3006260740 BARD MIDLINE; MIDLINE CATHETER Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/11/2021
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported "the midline team placed two midline catheters this weekend.They threaded the guidewire and went to advance the catheter but met resistance.They retracted the catheter and tried to reinsert, however the catheter would not thread, so they removed the device.Upon removal, part of the catheter sheared off and is lodged inside the patient." this report addresses the second patient and device.
 
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Brand Name
BARD MIDLINE
Type of Device
MIDLINE CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key12754627
MDR Text Key280259724
Report Number3006260740-2021-04661
Device Sequence Number1
Product Code PND
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received10/11/2021
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
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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