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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Entrapment of Device (1212); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2018
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 the guidewire removing the flow actuator from the catheter was confirmed and the cause appeared to be use-related. The product returned for evaluation was one accucath peripheral iv catheter assembly. The catheter was not returned for evaluation. Usage residues were observed throughout the sample. The safety button was depressed and the needle was fully withdrawn into the housing. The wire exhibited a 90 degree bend approximately 2cm proximal of the coil. The coils were misaligned but appeared intact. The flow actuator was observed within the housing. Microscopic inspection of the sample confirmed that the wire was intact. Inspection of the flow actuator was unremarkable. The retention features appeared well-formed. It appeared that the removal of the flow actuator was caused by inability of the actuator to pass the bent region of the guidewire. The guidewire bent and coil misalignment was consistent with attempted guidewire advancement into tissue or through a tortuous path. The usage residue indicated that guidewire damage occurred during attempted device placement. 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 upon retraction of accucath wire, it was observed that the wire caught on the blood control valve and pulled out the whole plastic part of the blood control valve. The catheter was removed and a new one was placed. No patient injury was reported. 1/22/2019 - returned wire is kinked.
 
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Brand NameACCUCATH INTRAVASCULAR CATHETER
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 Key8340889
MDR Text Key136509266
Report Number3006260740-2019-00252
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
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 02/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/31/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received01/22/2019
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

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