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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER

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BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Material Perforation (2205)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. 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 that a powerglide pro catheter was perforated by the needle. More information has been requested. Additional information stated, ¿guide wire was deployed, then the catheter was advanced. The catheter hit resistance so the catheter was retracted and then the guidewire was retracted. ¿.
 
Event Description
It was reported that a powerglide pro catheter was perforated by the needle. More information has been requested. Additional information stated, ¿guide wire was deployed, then the catheter was advanced. The catheter hit resistance so the catheter was retracted and then the guidewire was retracted¿.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the complaint of a perforated catheter is confirmed to be use related. One photo sample showing the distal end of the powerglide pro was returned for investigation. The needle is observed to be perforating the catheter near the midsection of the exposed needle length. The guidewire is extending out of the distal end of the needle unraveled and is looped through the split in the catheter. The needle piercing the catheter at the location observed in the photo sample provided is indicative of the catheter being retracted against the needle or the needle advance into the catheter once inserted. The ifu warns, ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the catheter. If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter. ¿.
 
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Brand NamePOWERGLIDE MIDLINE CATHETER
Type of DeviceMIDLINE CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8076134
MDR Text Key127407534
Report Number3006260740-2018-03243
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2018
Is This a Reprocessed and Reused Single-Use Device? No

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