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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 18 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BARD ACCESS SYSTEMS 18 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Break (1069); Material Frayed (1262); Installation-Related Problem (2965)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/02/2019
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redp3043 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the midline guide broke down at the time of the poses what led to a failed installation.Successful installation of another midline.No other information provided.
 
Event Description
It was reported that the midline guide broke down at the time of the poses what led to a failed installation.Successful installation of another midline.No other information provided.
 
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 18ga x 10cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.A break was observed in the core wire and the coil wire was elongated.A permanent bend was observed in the core wire distal of the break site.The weld tip was intact.Microscopic inspection of the needle revealed mechanical damage along the proximal edge of the bevel.Inspection of the wire break revealed a granular fracture surface.A tapered region of increased luster was observed.The needle bevel damage and the core wire break features were consistent with the wire being sheared against the needle bevel.Such damage can occur if the wire is retracted at a sharp angle against the needle bevel.
 
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Brand Name
18 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM 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 Key8946544
MDR Text Key156111840
Report Number3006260740-2019-02523
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741138607
UDI-Public(01)00801741138607
Combination Product (y/n)N
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number6F118100
Device Lot NumberREDP3043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2019
Event Location Hospital
Date Manufacturer Received09/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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