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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM INTERMEDIATE KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM INTERMEDIATE KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number F120081
Device Problem Material Twisted/Bent (2981)
Patient Problem Pain (1994)
Event Date 06/21/2018
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device has not been returned, at this time, to the manufacturer for evaluation. A lot history review (lhr) of recq0391 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that after placement, the midline had kinked internally and was causing pain. The device was subsequently removed. No patient injury was reported.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 kinked powerglide catheter was confirmed and the cause appeared to be use-related. The product returned for evaluation was one 20ga x 8cm powerglide midline catheter. The sample was received attached to an extension set. Usage residues were observed throughout the sample. A permanent kink impression was observed 2. 8cm from the distal tip of the catheter. Tactile inspection of the sample confirmed the presence of a permanent kink. Microscopic inspection of the distal end of the sample revealed buckling near the distal tip of the catheter. The tip of the catheter exhibited discoloration and deformation. The compressed and buckled tip of the catheter suggested that difficulty was experienced during catheter insertion. The kink in the tubing was consistent with device manipulation during that apparent insertion difficulty. A lot history review (lhr) of recq0391 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that after placement, the midline had kinked internally and was causing pain. The device was subsequently removed. No patient injury was reported.
 
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Brand Name20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM INTERMEDIATE KIT
Type of DeviceCATHETER,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
tesha udy
605 n. 5600 w.
salt lake city, UT 84116
8015225819
MDR Report Key7674299
MDR Text Key113743955
Report Number3006260740-2018-01659
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberF120081
Device Catalogue NumberF120081
Device Lot NumberRECQ0391
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received07/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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