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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

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BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 09/09/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reds0101 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the inside of the packaging box for the catheter affected was stained with ink from the text printed on the pouch.In addition, there was black dust on the white pouch of the catheter.The device was not used on a patient.
 
Event Description
It was reported that the inside of the packaging box for the catheter affected was stained with ink from the text printed on the pouch.In addition, there was black dust on the white pouch of the catheter.The device was not used on a patient.
 
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, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of foreign material in the device packaging was inconclusive due to poor sample condition.One opened 4 fr groshong nxt catheter kit was provided for evaluation.The kit product label indicted lot: reds0101.The outer tyvek lid was opened in order to inspect the inner tray containing the kit components.The catheter with the internal stiffening stylet was present within the tray along with a sealed statlock pouch.No black dust was observed in the tray.The statlock pouch was removed from the tray and no adhesion to the tray was noted.Microscopic of the inner and outer tray did not reveal any evidence of ink transfer from the statlock pouch.The print on the outer statlock pouch did not appear to have missing ink material.A spec of loose material was present within the opened inner tray.The spec appeared to have a light-brown color and appeared fibrous in nature.It is unknown if the light-brown particle was introduced into tray after package opening.The event description indicates that the tray was stained with ink from the printed pouch.The ink transfer on the kit tray may have appeared to be dark particles; however, as no evidence of ink material transfer was noted, the complaint could not be confirmed and remains inconclusive at this time.Although the complaint could not be confirmed from the sample provided, possible contributing factors to statlock pouch ink transfer include environmental storage conditions.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.
 
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Brand Name
GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10620566
MDR Text Key209603139
Report Number3006260740-2020-03431
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741086991
UDI-Public(01)00801741086991
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
Type of Report Initial,Followup
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2023
Device Model NumberN/A
Device Catalogue Number7617405
Device Lot NumberREDS0101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Event Location Hospital
Initial Date Manufacturer Received 09/09/2020
Initial Date FDA Received10/02/2020
Supplement Dates Manufacturer Received12/11/2020
Supplement Dates FDA Received12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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