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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH, ACE 20GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 ACCUCATH, ACE 20GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number AC1202250
Device Problems Material Frayed (1262); Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
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 manufacturer has received the sample and is pending evaluation. Results are expected soon. A lot history review (lhr) of reev1228 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by placer "i went to place an ultrasound iv. The patient had a decent antecubital vein. I got into the vein and it was a little tough-felt like a lot of scar tissue. I continued to walk my catheter into the vein. First attempt to slide wire was unsuccessful. I slid the wire back and continued to walk my catheter in. I then advanced my wire which felt smooth. Next went my catheter which was hard to advance about half in. Then tried to pull back my wire, which the pink slide busted off/slipped up. I retracted my needle with my white button which seemed to go fine. I could see my wire in the plastic part of the whole unit and my needle but the end of the catheter that is curled wasn¿t at the end so i was unsure what was left in the patient. The catheter remained in the patient and i couldn¿t pull it out. I asked the md to assist. He used lidocaine and pulled hard, and upon removal, the wire was partially in the patient along with the catheter. " additional information received 1/17/2021: it was reported this incident was painful for the patient. The catheter and wire were retrieved from the patient's arm with lidocaine and force.
 
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Brand NameACCUCATH, ACE 20GX2.25
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX 88780
Manufacturer Contact
kayla olsen
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key11207648
MDR Text Key229310019
Report Number3006260740-2021-00045
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162894
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAC1202250
Device Catalogue NumberAC1202250
Device Lot NumberREEV1228
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2020
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: 01/21/2021 Patient Sequence Number: 1
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