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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, 18GX1.25 BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS ACCUCATH, 18GX1.25 BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number AC0181250
Device Problems Detachment Of Device Component (1104); Failure to Advance (2524)
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, frequency 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 that the guidewire wouldn¿t advance with a subsequent inability to safety the accucath needle was inconclusive due to the sample condition.Two photographs were provided for investigation.The first photo showed the needle extending from the accucath handle.The safety mechanism button was visible in the photo.The proximal end of the handle was not captured in the photo.The guidewire was not extending from the distal tip of the needle.Due to the poor image quality, it could not be discerned if the curled tip of the guidewire was positioned at the distal tip of the needle.The 2nd photo showed the needle cover with a label for product code ac0181250 and lot # recp2386.It was reported that the guidewire functioned prior to insertion; however, after insertion, it was reported that the guidewire would not advance.It is possible that the guidewire met resistance while in the patient or became lodged within the needle.It was reported that the needle tip wouldn¿t pierce the vessel easily, which could be associated with the non-functioning guidewire.If the guidewire is not fully advanced when attempting to activate the safety mechanism, the safety mechanism may damage the guidewire, which can prevent the needle from fully retracting within the handle.A review of the manufacturing records showed no evidence that the reported event was caused by the mfg.Process.Since it was reported that the guidewire functioned prior to insertion, the device may have been damaged during use; however, based on the sample condition, the cause of the reported event was inconclusive.A lot history review (lhr) of recp2386 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported the that during placement the rn stuck the patient and couldn¿t see her needle tip after looking for a while.It was stated the rn found a shadow of the needle tip and it wouldn¿t pierce the vessel easily and she felt like it popped in.The rn tried to advance the wire but it wouldn¿t go (it worked prior to insertion).It was reported the accucath wouldn¿t safety and was pulled it out.It was noted that the needle was turned sideways and it would not safety and the wire would not advance.
 
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Brand Name
ACCUCATH, 18GX1.25 BASIC
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
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key7602585
MDR Text Key111849921
Report Number3006260740-2018-01377
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741110900
UDI-Public(01)00801741110900
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 Health Professional
Type of Report Initial
Report Date 06/14/2018
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 Expiration Date07/31/2019
Device Model NumberAC0181250
Device Catalogue NumberAC0181250
Device Lot NumberRECP2386
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2018
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 05/24/2018
Initial Date FDA Received06/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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