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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PFLEX, 20G 10CM BASIC KIT (POWERGLIDE PRO) INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS PFLEX, 20G 10CM BASIC KIT (POWERGLIDE PRO) INTRAVASCULAR CATHETER Back to Search Results
Model Number F120100
Device Problem Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2017
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), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the complaint of a damaged powerglide was confirmed and the cause appeared to be use-related. The product returned for evaluation was one 20ga x 10cm powerglide pro assembly. The sample was received assembled with the catheter overlaying the introducer needle. Usage residue were observed throughout the catheter and the needle. The guidewire extended through the needle and the catheter. The needle perforated the catheter. The inner core wire was broken and the outer coil wire was elongated. Microscopic inspection wire confirmed that the inner wire was broken and the outer was elongated. The weld tip was intact. The elongated region appeared to be confined to the region of wire within the needle. The catheter and guidewire damage were consistent with withdrawal against the needle bevel during attempted insertion. The product ifu states ¿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. ¿ a lot history review (lhr) of rebt1468 showed no other similar product complaint(s) from this lot number.
 
Event Description
Facility reported to sales rep that after multiple unsuccessful attempts to place the catheter the physician decided to remove the guidewire and attempt to place the device in a different location. When attempting to remove the guidewire the physician met resistance, he continued to try and remove the guidewire but it was stated that the guidewire "got stuck. " the guidewire wouldn't come out until the physician used "excessive force" and then "everything was pulled out of the patient's arm. " no patient injury reported.
 
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 rebt1468 showed no other similar product complaint(s) from this lot number.
 
Event Description
Facility reported to sales rep that after multiple unsuccessful attempts to place the catheter the physician decided to remove the guidewire and attempt to place the device in a different location. When attempting to remove the guidewire the physician met resistance, he continued to try and remove the guidewire but it was stated that the guidewire "got stuck. " the guidewire wouldn't come out until the physician used "excessive force" and then "everything was pulled out of the patient's arm. " no patient injury reported.
 
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Brand NamePFLEX, 20G 10CM BASIC KIT (POWERGLIDE PRO)
Type of DeviceINTRAVASCULAR CATHETER
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
teresa johnson
605 n. 5600 w.
salt lake city, UT 84116
8015225435
MDR Report Key7117021
MDR Text Key188749705
Report Number3006260740-2017-02228
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741110535
UDI-Public(01)00801741110535
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Model NumberF120100
Device Catalogue NumberF120100
Device Lot NumberREBT1468
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received01/05/2018
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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