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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE ST MIDLINE CATHETER FULL KIT (20G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS POWERGLIDE ST MIDLINE CATHETER FULL KIT (20G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/20/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redn1319 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that over the wire powerglide was inserted on patient in right upper arm in the er.Catheter kinked before leaving the patient's bedside.Unable to withdrawal blood.Had to reinsert different type of midline.
 
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Brand Name
POWERGLIDE ST MIDLINE CATHETER FULL KIT (20G) (8CM)
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
kayla olsen
605 n. 5600 w.
salt lake city, UT 84116
8015225010
MDR Report Key9169969
MDR Text Key161787446
Report Number3006260740-2019-02950
Device Sequence Number1
Product Code PND
UDI-Device Identifier00801741139314
UDI-Public(01)00801741139314
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/08/2019
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
Device Model NumberN/A
Device Catalogue NumberST220081
Device Lot NumberREDN1319
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 09/20/2019
Initial Date FDA Received10/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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