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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

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BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 Back to Search Results
Catalog Number AC0202250
Device Problems Detachment Of Device Component (1104); Stretched (1601)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2016
Event Type  Injury  
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), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the complaint of a damaged catheter and guidewire was confirmed, but the exact cause is unknown. One 20g accucath was returned for investigation. A visual observation of the returned sample revealed evidence of use. The needle and proximal portion of the guidewire had been retracted within the safety chamber. Blood residue was visible within the catheter. The distal coiled section of the guidewire was found around the catheter 4. 5cm from the distal end of the strain relief oversleeve. The 3cm of catheter distal to the wire was curved and exhibited multiple folds in the tubing. The distal tip of the catheter was crumpled. The valve actuator within the pink had not been advanced through the valve, which indicates that the catheter was not used. A microscopic examination showed a break in the guidewire. The coiled portion of the guidewire, which was around the catheter, was deformed and misshapen. It is unknown if any complications associated with the clinical setting affected the functional performance of the returned device. At this time, based on the evidence provided with the returned sample, it appears that the complications were encountered during the insertion process, but it is unknown what caused the damage to the catheter and guidewire. Warnings are contained in the ifu to prevent guidewire damage. No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use. A lot history review (lhr) of reas0535 showed no other similar product complaint(s) from this lot number.
 
Event Description
Per sales representative, a facility reported that an accucath catheter and guidewire was inserted smoothly with ultrasound technique. The nurse was able to pull the needle and wire out ok but the patient had vein spasms and vein squeaking, meaning that the vein was releasing the catheter. A warm compress was applied and the vascular surgeon was called to remove the device. They reported that the catheter looked like it had been stretched out and that the coiled tip from the wire detached and had wrapped around the catheter. A peripheral iv was placed. No patient injury reported.
 
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Brand NameACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
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 Key5765556
MDR Text Key48665972
Report Number3006260740-2016-00311
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
Type of Report Initial
Report Date 06/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/29/2017
Device Catalogue NumberAC0202250
Device Lot NumberREAS0535
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received06/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/01/2016 Patient Sequence Number: 1
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