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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER FULL KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER FULL KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Material Perforation (2205)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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 "a stiffer guidewire that was perforating and kicking the catheter" was inconclusive because the originally implicated device(s) was not returned for evaluation. The product returned for evaluation was one 18ga x 10cm powerglide midline catheter assembly. The sample was received in its original sealed packaging. Following opening of the sealed kit, inspection of the powerglide assembly was unremarkable. Attempts to advance and retract the guidewire were successful and unremarkable. Advancement of the catheter and deployment of the safety mechanism was successful and unremarkable. Tactile inspection of the advanced guidewire revealed that it felt similar in rigidity to that of a similar non-complainant device. Microscopic inspection of the guidewire carrier coupler was unremarkable. No deficiencies were discovered during evaluation of the returned sample; however, the sealed nature of the returned packaging indicated that the returned device was not the originally implicated device. Consequently this complaint is inconclusive at this time. A lot history review (lhr) of rebt0432 showed three other similar product complaint(s) from this lot number. The complaints for this lot number (rebt0432) have been reported from the same facility.
 
Event Description
It was reported that the nurse used a powerglide catheter and stated that the guidewire was stiffer than normal and perforated and "kicked" the catheter. No patient hard was reported. This report addresses the first of four devices used.
 
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 manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of rebt0432 showed three other similar product complaint(s) from this lot number. The complaints for this lot number (rebt0432) have been reported from the same facility.
 
Event Description
It was reported that the nurse used a powerglide catheter and stated that the guidewire was stiffer than normal and perforated and "kicked" the catheter. No patient hard was reported. This report addresses the first of four devices used.
 
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Brand NamePOWERGLIDE MIDLINE CATHETER FULL 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
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key7220684
MDR Text Key194237850
Report Number3006260740-2018-00052
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133856
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberM118101
Device Lot NumberREBT0432
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
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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