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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 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number AC0202250
Device Problems Material Frayed (1262); Difficult to Insert (1316); Difficult to Remove (1528); Sticking (1597); Physical Resistance (2578); Device Or Device Fragments Location Unknown (2590)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/19/2018
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 device has not been returned, at this time, to the manufacturer for evaluation. A lot history review (lhr) of reby2216 showed no other similar product complaint(s) from this lot number. [mw5076570. Pdf]. Device has not yet been returned for evaluation.
 
Event Description
It was reported that an accucath insertion using sonosite to guide was attempted after an unsuccessful attempt to first place a peripheral line. Vessel was reportedly very difficult to access, and a "pop" was felt during access of the vessel. Staff was able to see the end of the iv was placed in the middle of the vessel, and then advanced the guide wire without issue. When advancing the catheter over the guide wire the catheter was only able to advance halfway. Nurse attempted to de-access, but was unable to remove the catheter. When attempting to remove the stuck catheter, the catheter would pull on the guide wire, which was speculated to have been lodged in the vessel wall. A 'red cap' was placed on the line, and secured. A separate accucath line was placed in the other arm without issue. Patient was then re-positioned, and the catheter was removed from the arm with some resistance. No swelling, bruising, or pain was noted. The catheter that was removed had a tear with frayed edges in the middle. The wire was confirmed to be located in the vessel, and patient was taken to the or to remove the accucath and wire that remained in the arm.
 
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Brand NameACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
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 Key7555362
MDR Text Key109616824
Report Number3006260740-2018-01149
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741110948
UDI-Public(01)00801741110948
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 04/17/2018,05/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2019
Device Model NumberAC0202250
Device Catalogue NumberAC0202250
Device Lot NumberREBY2216
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/17/2018
Distributor Facility Aware Date03/19/2018
Event Location Hospital
Date Report to Manufacturer05/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2017
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: 05/30/2018 Patient Sequence Number: 1
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