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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 18GA, ACCUCATH IV CATHETER, 2.25", BASIC INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS 18GA, ACCUCATH IV CATHETER, 2.25", BASIC INTRAVASCULAR CATHETER Back to Search Results
Catalog Number AC0182250
Device Problems Difficult to Insert (1316); Physical Resistance (2578); Material Integrity Problem (2978)
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 manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
On (b)(6) 2016-it was reported by bard clinical specialist that during accucath training at a facility the rn inserted the needle into the patient under ultrasound. It was stated that the rn had difficulty inserting the guidewire and met resistance. The device was removed and it was noted that the end of the guidewire had a "double curl". Another device was used and was inserted successfully. It was reported that there was no patient harm.
 
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), and applicable fmea documents. Based on a review of this information, the following was concluded: the complaint of a double curl on the accucath wire is confirmed, and the cause is determined to be use-related. The device returned was one accucath intravascular delivery system and a loose catheter, reportedly from an 18 ga x 2. 25¿ accucath device. Visual observation of the device showed that the guidewire was protruding from the plastic body and the tip of the wire had two curls instead of the usual one. The white button was depressed and the guidewire slider and the needle were locked in the fully retracted position. Blood spatter was obvious throughout the inside of the plastic body. The catheter had some residue inside the tubing as well as around the valve actuator. Tactual evaluation showed a few kinks within the plastic of the catheter. Functional evaluation showed that the catheter was patent to infusion. The valve actuator was not fully engaged before the syringe was inserted, but engaged without issue. Microscopic observation showed that there was a hairpin bend in the wire at the coiled tip, causing the outer coils to be positioned outward and more distal to the others. Biological residue was apparent on the coils, and in particular at the site of the kink. The complaint description mentions encountering resistance while the device was within the patient, and noting the extra curl after retraction from the patient. The event occurred during use and this complaint is use-related. The resistance encountered during insertion and attendant manipulation of the wire is the likely cause of the observed state of the device. This resistance may have been encountered due to incomplete retraction of the guidewire, insertion of the device into or through tough tissue, and other insertion technique factors, or due to contact between the guidewire shaft and the needle tip. The current ifu for this product states: ¿insertion instructions: identify the vein and insertion site; clean and prep insertion site per your institution¿s policy; remove needle cover and inspect the catheter unit. Note: verify the guidewire coil (a) is present and not damaged (bent, kinked, etc. ). If guidewire tip is not present, contact bard access systems, inc; advance guidewire from current position by moving the slider (e) toward the catheter tip until it stops. Then fully retract the guidewire back into the needle by moving the slider away from the catheter tip. Note: be sure to move the slider all the way back until it stops and the coiled tip is not visible. If there is excessive force or the guidewire is unable to freely advance, contact bard access systems, inc. Guidewire must be fully retracted prior to vascular access; insert the needle into the vein and observe for blood return in the catheter. Note: if inserting at a steeper angle, lower catheter and stabilize before deploying the guidewire; slowly deploy guidewire into vessel by gently moving slider (e) toward catheter tip until fully deployed and it stops. Warning: do not force or retract the guidewire. Retracting the guidewire may increase the risk of guidewire damage. If the guidewire must be retracted, remove the entire device to prevent the needle from damaging or shearing the guidewire. ¿.
 
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Brand Name18GA, ACCUCATH IV CATHETER, 2.25", BASIC
Type of DeviceINTRAVASCULAR CATHETER
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
maren treft
605 n. 5600 w.
salt lake city, UT 84116
8015225964
MDR Report Key6149555
MDR Text Key61906005
Report Number3006260740-2016-00646
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741110931
UDI-Public(01)00801741110931
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAC0182250
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received01/03/2017
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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