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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 SL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number 7655405
Device Problems Defective Component (2292); Infusion or Flow Problem (2964); Material Twisted/Bent (2981)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redp1988 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported the patient was implanted a set of 7655405 catheter on (b)(6) 2020.The operator opened the package and found that there was a crease about 2 cm at the valve end of the catheter, and the valve was always open.Insufficient valve regurgitation occurs and blood return occurs, and a new set of catheters is reopened for use.
 
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 following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking valve is confirmed and was determined to be manufacturing related.One 4 fr single lumen groshong clearvue catheter with a stiffening stylet and flushing hub inserted was returned for evaluation.An initial visual observation showed no obvious evidence of use on the returned sample.The returned sample was flushed with a 12 ml syringe of water and was found to be patent to infusion and aspiration and no leaks were found.However, once the catheter was flushed and filled with water and then detached from the syringe, small but steady drips were observed emanating from the valve.A microscopic observation revealed the valve slit of the catheter was not entirely straight and was slightly curved near its center.The investigation has been forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.
 
Event Description
It was reported the patient was implanted a set of 7655405 catheter on (b)(6) 2020.The operator opened the package and found that there was a crease about 2 cm at the valve end of the catheter, and the valve was always open.Insufficient valve regurgitation occurs and blood return occurs, and a new set of catheters is reopened for use.
 
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Brand Name
GROSHONG NXT CLEARVUE 4F SL
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
MDR Report Key10944416
MDR Text Key220240696
Report Number3006260740-2020-20774
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741035272
UDI-Public(01)00801741035272
Combination Product (y/n)N
PMA/PMN Number
K034020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7655405
Device Catalogue Number7655405
Device Lot NumberREDP1988
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Date Manufacturer Received02/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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