Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER, 18G 10CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER, 18G 10CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
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) review is not possible, as no manufacturing lot number has been provided by the complainant.Device has not yet been returned for evaluation.
 
Event Description
It was reported that the nurse placing the line noted that as he started to advance the catheter there was a slight tightness and then it stopped advancing.It was stated the nurse then started to pull the catheter back over the guidewire and it would not pull back, the patient complained of it hurting, so he pulled the entire line out.The guidewire was fully advanced into place.Once pulled out it was noted that the guidewire had pierced the catheter.
 
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 complications during the insertion procedure is confirmed.The product implicated is a 5 fr powerpicc solo.The product returned is a 20 ga powerglide pro.The condition of the returned sample appears to match the event information provided.Use residue was observed throughout the device.The slider was returned fully advanced and the guidewire extended 34 mm from the distal end of the needle.The catheter wings and the catheter were partially advanced but still within the device housing.The distal end of the guidewire was extending from the catheter 1.5 mm.The catheter was observed to be punctured by the needle 34 mm from the distal end which is indicative of the catheter being retracted against the needle bevel.The catheter was advanced and removed successfully from the device with slight resistance that appeared to be caused by the dried residue.The damage observed on the device appeared to be cause by improper procedure; therefore the complaint of complications during the insertion procedure is confirmed.The ifu states, ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.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¿ and ¿while holding the catheter wings in place, fully remove housing from the catheter.¿ 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 the nurse placing the line noted that as he started to advance the catheter there was a slight tightness and then it stopped advancing.It was stated the nurse then started to pull the catheter back over the guidewire and it would not pull back, the patient complained of it hurting, so he pulled the entire line out.The guidewire was fully advanced into place.Once pulled out it was noted that the guidewire had pierced the catheter.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POWERGLIDE MIDLINE CATHETER, 18G 10CM
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
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 Key7450643
MDR Text Key106314915
Report Number3006260740-2018-00794
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741038105
UDI-Public(01)00801741038105
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 Health Professional
Type of Report Initial,Followup
Report Date 05/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberM118100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2018
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received05/11/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-