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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH GUARDIVA AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH GUARDIVA AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/14/2020
Event Type  Injury  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of rees0340 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported "we had a recent incident with the powerglide pro midline catheter that needs to be reported for investigation as the tip broke off in the patient. " add info rcvd 09/29/2020: during attempt to insert midline to lue cephalic vein, the catheter was slowly advanced but resistance was felt right away. Pt also complained of pain. Immediately, the entire midline unit was removed from patient¿s arm. Upon assessment of midline needle, it was found that approximately 1 cm of the catheter was missing. Catheter was able to be visualized by this rn within arm tissue using ultrasound machine. Pressure was applied with gauze to the needle insertion site and the tourniquet was left in place. The primary rn was informed right away, as well as the attending md consulted ir for recommendation. Within a few minutes, dr. Returned phone call and spoke to this rn regarding situation and quickly arrived to bedside to assess patient. Dr. Assessed patient¿s arm with ultrasound machine and confirmed 1 cm of catheter was visible within arm. Dr. Released the tourniquet and recommended obtaining a venous doppler study within 24 hours, and to leave the catheter tip where it was. ".
 
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Brand NameFULL KIT 20G X 10 CM WITH GUARDIVA AND PROBE COVER
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
kelsey erickson
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key10690487
MDR Text Key211728680
Report Number3006260740-2020-20142
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 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberF120108PT
Device Lot NumberREES0340
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2020
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: 10/16/2020 Patient Sequence Number: 1
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