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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number F318108PT
Device Problems Retraction Problem (1536); Failure to Advance (2524)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/08/2020
Event Type  Injury  
Manufacturer Narrative
The manufacturer has received the sample and will be evaluated. Results are expected soon. A lot history review (lhr) of reer0591 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported "customer was placing powerglide. When she removed the powerglide, the guidewire was coiled and the catheter was sheared. A piece of the catheter remained in the patient's tissue. They confirmed it was not in the patient's vein. " additional information received 10/27/2020: ¿i inserted the needle, bevel up, into the skin. Visualized the needle inside the vein, obtained blood flash in the chamber, and deployed the guide wire. It made a clicking sound when it reached the bottom of the device. I then tried to deploy the cathlon and it wouldn't advance. I tried once more, and again it wouldn advance. I then attempted to remove the entire device. The guide wire wouldn't retract, so i attempted to remove the whole device, but only the body would pull out. The cathlon pulled out most of the way but was snagged just under the skin at the insertion site. I called the provider to the room, we were able to forcefully remove the cathlon, but when measured, there was approximately 2 cm missing. Device pictured is exactly how the device came out of the patients upper arm, sans the cathlon, which was measured and discarded. ¿.
 
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Brand NameFULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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
shelly gilbert
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key10809644
MDR Text Key215326563
Report Number3006260740-2020-20405
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162377
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 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Model NumberF318108PT
Device Catalogue NumberF318108PT
Device Lot NumberREER0591
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2020
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: 11/09/2020 Patient Sequence Number: 1
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