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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number F118108PT
Device Problems Material Perforation (2205); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 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 the catheter being perforated by the 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. Blood residue was observed throughout the sample. The catheter was partially extended on the needle shaft. The tip of the wire protruded from the catheter. A loop of wire protruded from a longitudinally aligned split in the catheter near the distal end. Microscopic inspection of the distal end of the catheter revealed deformation and discoloration. The loop of guidewire extended from a tear in the catheter. Deformation and discoloration were observed in the vicinity of the tear. A break was observed in the inner core wire and the coil wire was elongated. The weld tip was intact. Inspection of the break in the core wire revealed a granular fracture surface. The fracture exhibited a region of increased luster. Inspection of the needle bevel outward flaring deformation along the proximal edge. The guidewire and catheter deformation were consistent with attempted device insertion against resistance. Such resistance can occur if insertion into tissue is attempted and if insertion is attempted at a steep insertion angle. The needle bevel damage and guidewire breakage were consistent with damage initiated by withdrawal of the wire against the needle bevel. The product ifu states ¿do not perforate, tear, or fracture the catheter with the needle or guidewire during the procedure. ¿ a lot history review (lhr) of recs0355 showed no other similar product complaint(s) from this lot number.
 
Event Description
The facility reported that during placement of the powerglide, the rn deployed the guidewire once believed she was in the vein. The rn then deployed the catheter and met resistance then pulled back the catheter and met resistance again. It was stated that the device was removed all together (guidewire and catheter) and it was noted the guidewire had perforated the side of the catheter. It was reported there was no harm to the patient and a new device was placed successfully.
 
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Brand NameFULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER
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 Key7877683
MDR Text Key120521724
Report Number3006260740-2018-02471
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 09/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberF118108PT
Device Catalogue NumberF118108PT
Device Lot NumberRECS0355
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received08/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2018
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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