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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; 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; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/10/2022
Event Type  Injury  
Event Description
It was reported that the connection between the extension tubing connector and oversleeve portion was exposed externally completely four days after catheter placement.With the addressing intact, the entire catheter slipped into the body and was removed in an interventional manner on the same day.No residue of the catheter remained in the body.The vital signs of the patient were stable and will be followed up.When analyzing the cause with the head nurse of the department, the nurse placing the catheter revealed that the oversleeve portion was attached with the connector tightly without loose on the day of insertion.The oversleeve portion and the connector appeared undamaged.Infusion was done smoothly through 4 days after placement, which was the first cycle of chemotherapy.During the period of time, blood could be drawn and the catheter was flushed without violently, no power injection inspection was conducted.No catheter tearing, no strenuous exercises.
 
Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refy3857 showed no other similar product complaint(s) from this lot number.
 
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 detached catheter is confirmed; however, the exact cause is unknown.One video of a groshong nxt catheter was returned for evaluation.An initial visual observation of the video showed an attempt to connect a groshong clearvue catheter to a two-piece groshong nxt connector.The catheter was threaded through the distal connector piece without issue and its proximal end was slid onto the metal cannula of the proximal connector piece and pushed up against the grey plastic of the proximal connector piece.Then the connector was assembled without issue and appeared to have a firm connection.Then an attempt was made to pull the catheter out of the assembled connector and the catheter was found to become detached with what appeared to be little force.The catheter did not appear to break and was not observed to stretch significantly.This can occur if the blue compression sleeve within the distal connector piece was missing or removed.However, without closer inspection of the products involved in the reported event, it was not possible to determine the root cause of the issue shown in the returned video.H3 other text : evaluation findings are in section h.11.
 
Event Description
It was reported that the connection between the extension tubing connector and oversleeve portion was exposed externally completely four days after catheter placement.With the addressing intact, the entire catheter slipped into the body and was removed in an interventional manner on the same day.No residue of the catheter remained in the body.The vital signs of the patient were stable and will be followed up.When analyzing the cause with the head nurse of the department, the nurse placing the catheter revealed that the oversleeve portion was attached with the connector tightly without loose on the day of insertion.The oversleeve portion and the connector appeared undamaged.Infusion was done smoothly through 4 days after placement, which was the first cycle of chemotherapy.During the period of time, blood could be drawn and the catheter was flushed without violently, no power injection inspection was conducted.No catheter tearing, no strenuous exercises.
 
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Brand Name
GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY
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
becky garcia
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key15712509
MDR Text Key302825709
Report Number3006260740-2022-04248
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
Report Date 11/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2022
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 NumberREFY3857
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2021
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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