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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, ACE 18GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BARD ACCESS SYSTEMS ACCUCATH, ACE 18GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Material Deformation (2976); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/02/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redq2618 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redq2618) have been reported from the same facility.
 
Event Description
The rn reported, "i had good blood return and good visual of the needle at the center of the vein.I advanced the guidewire and met resistance halfway and retracted.The guidewire was then stuck.I entered the vein a little higher and threaded the catheter in for a successful iv without use of the guidewire.The safety device would not work.We removed the needle and the guidewire was not visible.I assume it was looped inside the needle.".
 
Event Description
The rn reported, "i had good blood return and good visual of the needle at the center of the vein.I advanced the guidewire and met resistance halfway and retracted.The guidewire was then stuck.I entered the vein a little higher and threaded the catheter in for a successful iv without use of the guidewire.The safety device would not work.We removed the needle and the guidewire was not visible.I assume it was looped inside the needle.".
 
Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.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 difficult guidewire insertion was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga x 2.25¿ accucath ace peripheral iv catheter assembly.The catheter was removed from the needle and was not returned.Blood residue was observed throughout the sample.The guidewire did not protrude from the needle tip.The safety button was depressed; however, the needle was not withdrawn into the housing.Microscopic inspection of the flash notch in the needle confirmed the presence of coagulated blood products.Initial attempts to advance the guidewire were unsuccessful, which appeared to have prevented safety activation.Guidewire mobility was reestablished through gentle manipulation.Blood products were cleared from the needle bore during manipulation.The guidewire was intact.Curved shape memory was observed near the coil region.Microscopic inspection of the wire confirmed it to be intact.The guidewire appeared to be adhered inside the needle shaft by blood products upon sample receipt, which prevented guidewire advancement and safety mechanism activation.The guidewire curved shape memory was consistent with attempted advancement against resistance, such as into tissue.It appeared that initially difficult with guidewire deployment led to guidewire withdrawal and a procedural delay that allowed blood products to coagulate within the needle which interfered with guidewire mobility.The product ifu states ¿warning: do not force or retract the guidewire.¿ a lot history review (lhr) of redq2618 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redq2618) have been reported from the same facility.
 
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Brand Name
ACCUCATH, ACE 18GX2.25
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
MDR Report Key9627178
MDR Text Key193693198
Report Number3006260740-2020-00288
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741137945
UDI-Public(01)00801741137945
Combination Product (y/n)N
PMA/PMN Number
K162894
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberAC1182250
Device Lot NumberREDQ2618
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2020
Event Location Hospital
Initial Date Manufacturer Received 01/02/2020
Initial Date FDA Received01/24/2020
Supplement Dates Manufacturer Received01/30/2020
Supplement Dates FDA Received02/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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