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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 22 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BARD ACCESS SYSTEMS 22 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/11/2019
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redp5035 showed no other similar product complaint(s) from this lot number.
 
Event Description
It's was reported that "after successful insertion of the powerglide pro midline catheter and on attempting to remove the guidewire there was resistant, so the resident pulled with a bit of force so the handle of the introducer came out but without the guidewire.We attempted to flush the catheter but it did not flush so the catheter was removed.We found that the catheter has piece of the guidewire inside it, so we flushed the catheter until we got the piece of the guidewire out.".
 
Event Description
It's was reported that "after successful insertion of the powerglide pro midline catheter and on attempting to remove the guidewire there was resistant, so the resident pulled with a bit of force so the handle of the introducer came out but without the guidewire.We attempted to flush the catheter but it did not flush so the catheter was removed.We found that the catheter has piece of the guidewire inside it, so we flushed the catheter until we got the piece of the guidewire out.".
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 22ga x 8cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter was advanced and the safety mechanism was engaged.The guidewire exhibited complete breaks in both the core and coil wires.The distal segment of the guidewire, including the weld tip was received separated from the assembly.Curved shape memory was observed in the catheter shaft.Microscopic inspection of the guidewire break site revealed a granular fracture surface.Necking was observed in the vicinity of the break.Localized elongation of the coil wire was observed near the break site.The break in the guidewire was consistent with material failure due to tensile (pulling) stress.The catheter shaft deformation was consistent with attempted advancement through a tortuous pathway.It appeared that the wire became constrained within the catheter, and broke during subsequent pulling.A lot history review (lhr) of redp5035 showed no other similar product complaint(s) from this lot number.
 
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Brand Name
22 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT
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
MDR Report Key9285382
MDR Text Key165394183
Report Number3006260740-2019-03455
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741138638
UDI-Public(01)00801741138638
Combination Product (y/n)N
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/13/2019
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 Number6F122080
Device Lot NumberREDP5035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2019
Event Location Hospital
Initial Date Manufacturer Received 10/14/2019
Initial Date FDA Received11/06/2019
Supplement Dates Manufacturer Received12/04/2019
Supplement Dates FDA Received12/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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