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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY W/MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY W/MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Thrombosis/Thrombus (4440)
Event Date 03/24/2023
Event Type  Injury  
Event Description
It was reported that the patient had a sensation of swelling at the insertion site during maintenance of the catheter.The department has removed the catheter from the patient.This patient underwent diagnosis by ultrasound upon awareness of swelling at the insertion site, which indicated thrombosis surrounding the basilic vein and the axillary vein.
 
Manufacturer Narrative
H11: section a through f - 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 will evaluate.Results are expected soon.
 
Manufacturer Narrative
H11: section a through f - 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.
 
Event Description
It was reported that the patient had a sensation of swelling at the insertion site during maintenance of the catheter.The department has removed the catheter from the patient.This patient underwent diagnosis by ultrasound upon awareness of swelling at the insertion site, which indicated thrombosis surrounding the basilic vein and the axillary vein.Additional information received 04/24/2024: after thrombosis was found, the head nurse immediately extubed the tube and gave the patient anti-inflammatory and analgesic treatment.The patient was discharged from hospital within a week.Patient experienced pain and stiffness at the puncture point on the right arm.
 
Manufacturer Narrative
H11: section a through f - 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 complaint of a catheter causing swelling in the arm near the insertion site was confirmed.The product returned for evaluation was one 4 fr s/l groshong catheter.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated and a split was observed between the 37 cm and 38 cm depth markings.The catheter split contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: damage which was circumferentially aligned.Fracture edges which were rounded and polished due to repeated material wear.'c' shaped impressions leading into the fracture site which are consistent with material buckling due to movement which caused the fracture edges to be pressed together.Overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing).An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.The damage location suggested that catheter securement, access and maintenance techniques may have contributed.
 
Event Description
It was reported that the patient had a sensation of swelling at the insertion site during maintenance of the catheter.The department has removed the catheter from the patient.This patient underwent diagnosis by ultrasound upon awareness of swelling at the insertion site, which indicated thrombosis surrounding the basilic vein and the axillary vein.Additional information received 04/24/2024: after thrombosis was found, the head nurse immediately extubed the tube and gave the patient anti-inflammatory and analgesic treatment.The patient was discharged from hospital within a week.Patient experienced pain and stiffness at the puncture point on the right arm.
 
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Brand Name
GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY W/MICROINTRODUCER
Type of Device
CATHETER,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
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key16765533
MDR Text Key313540648
Report Number3006260740-2023-01400
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741035272
UDI-Public(01)00801741035272
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K034020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number7655405
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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