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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Break (1069); Failure to Advance (2524)
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), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the complaint of inability to advance the catheter was confirmed and the cause appeared to be use-related. The product returned for evaluation was one 20ga x 2. 25¿ accucath peripheral iv catheter assembly. The sample was received assembled with the catheter overlaying the needle shaft. Blood residue was observed throughout the catheter. The guidewire did not protrude from the needle shaft. Attempts to advance the guidewire were initially unsuccessful. Following removal of the catheter, inspection of the flash notch did not reveal the guidewire. Following removal of the catheter, advancement of the wire slider caused the wire to protrude from the flash notch. Microscopic inspection of the guidewire revealed a complete break within the coiled region. Curved shape memory was observed in the vicinity of the break. The break surface exhibited a granular fracture surface. A region of increased luster was observed. Microscopic inspection of the needle bevel revealed mechanical damage along the proximal edge. The inability to advance the guidewire was caused by the guidewire exiting the needle flash notch. This was caused by the wire being shortened by a break within the coil region. The break characteristics and needle bevel deformation were consistent with damage caused by wire retraction against the needle bevel. Such damage can occur if insertion is attempted into tissue or at a too-steep insertion angle, followed by wire retraction. A lot history review (lhr) of recx1915 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the guidewire did not advance once inserted in the patient. On (b)(6) 2019 - returned wire is broken.
 
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Brand NameACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
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 Key8483310
MDR Text Key141095600
Report Number3006260740-2019-00774
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberAC0202250
Device Lot NumberRECX1915
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received03/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2018
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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